MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL UNILOCK-SCR 3 SELF-TAP L10 5U SCREW,FIXATION,BONE

Catalog Number 413.580.05

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

Occupation: initial reporter is synthes sales representative. Pma/510(k): device is not distributed in the united states, but is similar to device marketed in the usa. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, upon inspection of incoming goods by the distributor, a sternal unilock screw pack of five (5), only had four (4) screws inside the packaging were received. Another device was used to complete the surgery. There was no adverse consequences to the patient reported. This report is for one (1) sternal unilock-scr ø3 self-tap l10 5u. This is report 1 of 1 for (b)(4).

• Brand Name: STERNAL UNILOCK-SCR 3 SELF-TAP L10 5U
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8666409
• MDR Text Key: 146933253
• Report Number: 8030965-2019-64846
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (Y/N): N
• Reporter Country Code: CH
• PMA/PMN Number: K093772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/06/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/04/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 413.580.05
• Device LOT Number: H719926
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/19/2018
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown