N
Patient 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MAUDE MDR 6268835
- MDR report key
- 6268835
- Report number
- 1221934-2017-10026
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-27
- Date received
- 2017-01-20
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. JENNIFER LAWRENCE
- Address
- 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
- Phone
- 508-508-5089
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 1393 5.9MM STRYKER OBTURATOR 1392 -NS | MITEK FMS OBTURATORS | DEPUY MITEK | HRX | 281393 | Y | Y | |||||
| 1 | 1393 5.9MM STRYKER OBTURATOR 1392 -NS | MITEK FMS OBTURATORS | DEPUY MITEK | HNX | 281393 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-20 | 0 |
Event Narratives#
D
Patient 1
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.
N
Patient 1
D
Patient 1
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.
N
Patient 1
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).