MAUDE Adverse Event Report: SYNTHES GMBH LWPROF METAPHYS COMPRES SCR ø2.7 SELF-TA; SCREW, FIXATION, BONE

Catalog Number	04.118.520TS
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2024, the patient underwent an orif surgery for a clavicle fracture.The surgeon inserted the locking screw in question into the 3rd hole from the distal end.Since the surgeon felt that he was tightening the locking screw normally, he stopped tightening the locking screw, although he felt that there was a slight gap between the screw head and the plate.Locking screws were then inserted into the 4th and most distal hole.However, at this point, the surgeon was concerned about the gap between the head of the screw inserted in the 3rd hole from the distal end and the plate, so he retightened that locking screw.When the surgeon tried to remove the screwdriver from the screw head, the screw broke off at its neck and only the screw head was attached to the screwdriver tip.The surgeon inserted the rest of the locking screws and completed the surgery with the shaft of the broken locking screw remained in the patient¿s body.The surgery was completed successfully within 30 minutes delay.Patient outcome, stable.No further information is available.This report is for one (1) lwprof metaphys compres scr ã¸2.7 self-ta this is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hrs d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.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.
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.H4,h6 part # 04.118.520ts, lot # 8l46256, manufacturing site: werk selzach logistik , release to warehouse date: 06.Aug.2021, expiration date: 01.Aug.2026, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.118.520, non-sterile lot # 281p745, manufacturing site: werk selzach logistik, release to warehouse date: 14.July.2021, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: LWPROF METAPHYS COMPRES SCR ø2.7 SELF-TA
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18594713
• Report Number: 8030965-2024-01418
• Device Sequence Number: 15134950
• Product Code: HWC
• UDI-Device Identifier: 10886982108845
• UDI-Public: (01)10886982108845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: 04.118.520TS
• Device Lot Number: 8L46256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown