MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.524S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, during final hand tightening of the screw in question implanted through a short tfna aiming arm, the resident snapped the head off of the screw against the lateral cortex.The screw broke at the very beginning of the screw head/shaft junction.The surgeon successfully removed the fragment of the screw head from the patient.The shaft remained in place across both cortices.The procedure was completed successfully with a surgical delay for removing the broken screw head.A larger incision was required to remove the fragment.No further information is available.This report is for a 5.0mm ti locking screw w/t25 stardrive 34mm f/im nail-ster.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Manufacturing location: (b)(4).Manufacturing date: 14-jun-2022; expiration date: 30-apr-2032; part number: 04.005.524s, 5.0mm ti locking screw w/t25 stardrive 34mm f/im nail ¿ sterile; lot number: 857p724 (sterile); lot quantity: 120; part number: 04.005.524.999, 5.0mm ti screw blank 34mm 05.0 nail lock screw w/sd25; lot number: 726p720; lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 23020, tialnbci4.98; lot number: 651p859; lot quantity: 1,523 lbs.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15744702
• Report Number: 8030965-2022-09421
• Device Sequence Number: 7074968
• Product Code: HWC
• UDI-Device Identifier: 10886982085931
• UDI-Public: (01)10886982085931
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.005.524S
• Device Catalogue Number: 04.005.524S
• Device Lot Number: 857P724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2022
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female