MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-20 for 1393 5.9MM STRYKER OBTURATOR 1392 -NS 281393 manufactured by Depuy Mitek.
[65462177]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[65462178]
The sales rep reported via phone that during an acl procedure an inch and a half long piece of the tip of the customer's stryker obturator broke off into the patient. All pieces and debris were removed from the patient. The case was completed with a replacement device. There were no patient consequences but a 15-20 minute delay was reported. The device is being returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[73480229]
Patient Sequence No: 1, Text Type: N, H10
[73480230]
The sales rep reported via phone that during an acl procedure an inch and a half long piece of the tip of the customer's stryker obturator broke off into the patient. All pieces and debris were removed from the patient. The case was completed with a replacement device. There were no patient consequences but a 15-20 minute delay was reported. The device is being returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[74825680]
The complaint device was received and visually inspected. Visual observations revealed that the distal tip was broken off the device, confirming the complaint. Historically, this type of failure is associated with excessive force applied during application. A dhr has been and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this serial number that was released to distribution. At this point in time, no further action is warranted. However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2017-10026 |
| MDR Report Key | 6268835 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-20 |
| Date of Report | 2016-12-27 |
| Date of Event | 2016-12-27 |
| Report Date | 2016-12-27 |
| Date Reported to Mfgr | 2016-12-27 |
| Date Mfgr Received | 2017-05-02 |
| Device Manufacturer Date | 2015-06-23 |
| Date Added to Maude | 2017-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776860 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1393 5.9MM STRYKER OBTURATOR 1392 -NS |
| Generic Name | MITEK FMS OBTURATORS |
| Product Code | HRX |
| Date Received | 2017-01-20 |
| Catalog Number | 281393 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Brand Name | 1393 5.9MM STRYKER OBTURATOR 1392 -NS |
| Generic Name | MITEK FMS OBTURATORS |
| Product Code | HNX |
| Date Received | 2017-01-20 |
| Returned To Mfg | 2017-03-07 |
| Catalog Number | 281393 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-20 |