MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for 4MM FEMORAL AIMER 234-020-044 0234020044 manufactured by Stryker Endoscopy-san Jose.
[186349512]
Alleged failure: the 2 drill bit were returned because after the first use (ok-no problem) it rubs when passing (+overheating) through the guide and then it blocks. The failure alleged in the complaint record was not confirmed/duplicated during the product investigation. The probable root causes could be: excessive force applied on device or rough handling during reprocessing. The product was returned for investigation and the failure mode will be monitored for future reoccurrence. The device manufacturer date is not known.
Patient Sequence No: 1, Text Type: N, H10
[186349513]
Per investigation results, the tip of the device was broken off. Per the event description, there is no alleged patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2020-00125 |
| MDR Report Key | 9835924 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-16 |
| 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 | MR. ANDREA ZENERE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4MM FEMORAL AIMER |
| Generic Name | ACCESSORIES, ARTHROSCOPIC |
| Product Code | NBH |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-02-04 |
| Model Number | 234-020-044 |
| Catalog Number | 0234020044 |
| Lot Number | 623710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |