MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-09-15 for HEWSON SUTURE RETRIEVER 71111579 manufactured by Smith & Nephew, Inc..
[86327327]
Patient Sequence No: 1, Text Type: N, H10
[86327328]
It was reported that during a partial patellectomy with patellar tendon advancement for patella fracture a smith & nephew hewson suture retriever was being used when a piece of the passer loop broke off and was unable to be retrieved.
Patient Sequence No: 1, Text Type: D, B5
[106341896]
The associated complaint device was not returned for evaluation. It was reported that a piece of the passer loop from the hewson suture retriever broke off and was unable to be retrieved, and remains in the patient. It has been requested to identify the exact piece of the device that is retained, as there are different material compositions for each component of the device. Therefore, without knowing what portion remains in the patient at this time, the material composition/biocompatibility cannot be determined at this time. Additional communication states that the patient has exhibited no adverse symptoms to this date, and the need for revision surgery has not been indicated. The future impact to the patient cannot be determined. No further clinical assessment can be performed. A review of complaint history did not reveal additional complaints for the listed batch. A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. Based on this investigation, the need for corrective action is not indicated. No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary. Should the device or additional information be received, the complaint will be reopened. We consider this investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2017-00750 |
| MDR Report Key | 6869245 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-09-15 |
| Date of Report | 2018-04-24 |
| Date of Event | 2017-08-21 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2017-03-20 |
| Date Added to Maude | 2017-09-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | ROBERT RUST |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEWSON SUTURE RETRIEVER |
| Generic Name | RETENTION DEVICE, SUTURE |
| Product Code | KGS |
| Date Received | 2017-09-15 |
| Catalog Number | 71111579 |
| Lot Number | 17CSM0077 |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-15 |