MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 75MM; PLATE, FIXATION, BONE

Catalog Number 212.224

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the screws were found to be cross threaded.This report involves one (1) 5.0mm locking screw slf-tpng with t25 stardrive recess 75mm.This is report 3 of 8 for (b)(4).

Manufacturer Narrative

Additional device product codes: ktt and hwc.Reporter is a synthes employee.Product code: 212.224, lot number: 105p234, manufacturing site: (b)(4) release to warehouse date: april 14, 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Visual inspection: the complaint device (lockscr ø5 self-tap l75 sst) was returned for investigation.Upon physical review of the device.It was detected that locking screw presented a high worn condition on threads which could be caused during device extraction.Also head's drive presents visible wear damages possibly created by the force stress which was loaded into it during explantation.It was tested with a screwdriver and head's drive remains functional.Device failure/defect identified? yes, damages were observed at the screw threads.Functional test: no functional test was performed, no mating device was returned.Dimensional inspection: dimensional inspection not performed, damage at the device was created after manufacturing process.Document/specification review: lockscr ø5 self-tap l75 sst: se_131096, current revision.Complaint confirmed: yes, screw was worn/stripped.Investigation conclusion: the complaint device (lockscr ø5 self-tap l75 sst) was returned for investigation.Upon physical review of the device.It was detected that locking screw presented a high worn condition on threads which could be caused during device extraction.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 75MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13109978
• MDR Text Key: 286269960
• Report Number: 8030965-2021-10516
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819124905
• UDI-Public: (01)07611819124905
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212.224
• Device Lot Number: 105P234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1