MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 22MM; APPLIANCE,FIXATION,NAIL

Catalog Number 412.107

Device Problems Material Disintegration (1177); Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Date of event is unknown.Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Reporter¿s phone number is not provided.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 europe reports an event in (b)(6) as follows: it was reported that during a surgery the stardrive screw's thread disintegrated during the screwing to an locking compression plate (lcp).No surgical delay is reported.Concomitant device reported: locking compression plate (part # unknown, lot # unknown, quantity 1).This report is for one (1) 3.5mm ti locking screw self-tapping with stardrive recess 22mm.(b)(4).

Manufacturer Narrative

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

It was further reported that the surgeon had to change the screw.The surgery was completed successfully with five (5) minutes delay.

Manufacturer Narrative

Therapy date is 10/20/2017.A device history record (dhr) review was performed for part number: 412.107, synthes lot number: 9897867, release to warehouse date: 31.March 2016: manufacturing site: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Our investigation has shown that we have received one (1) screw back.There are mechanical damages visible at the screw head-recess as well as at threaded-shaft, so that affected areas have no anodized layer anymore.However, because of these findings this complaint is rated as confirmed.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately, we only have limited information in the complaint description and cannot confirm how this happened.We do suppose that the screw was damaged during insertion, e.G.Was not inserted aligned.Because of the damage the complaint relevant dimensions cannot be checked for dimensional accuracy.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's.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.

• Brand Name: 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 22MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7122374
• MDR Text Key: 95057957
• Report Number: 8030965-2017-50747
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819126084
• UDI-Public: (01)07611819126084(10)9897867
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.107
• Device Lot Number: 9897867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR