MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 28MM PLATE,FIXATION,BONE

Catalog Number 04.200.028TS

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hwc. Reporter is a j&j employee. The device has been 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 during an unknown procedure on (b)(6) 2020 it was identified that the inner part with the screw of the steril-tube got stuck in the outer part. There was no surgical delay. Procedure was not completed successfully. No patient consequences reported. This report is for one (1) 3. 5mm ti stardrive cortex screw self-tapping 28mm. This is report 8 of 10 for (b)(4). This complaint is linked to (b)(4).

• Brand Name: 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 28MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10309443
• MDR Text Key: 199921628
• Report Number: 8030965-2020-05146
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.200.028TS
• Device Lot Number: 6L42767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown