MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI HEADLESS COMPRESSION SCR/SHORT THRD/80MM-STERILE; SCREW, FIXATION, BONE

Model Number	04.226.680S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
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.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 or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, during orif surgery for transverse fracture of shaft of clavicle, the screw in question was planned to be inserted into the medullary cavity.The surgeon drilled only the proximal cortex to insert the screw and started insertion.Since the patient was young, the medullary cavity was narrow, and a guide wire was inserted slightly flexed.The bone felt hard when the screw was inserted, but the surgeon kept inserting with force, and when the image intensifier was checked after the screw was inserted to some extent, the screw was found to be broken in the area between the threaded part and the shaft.The surgeon inserted additional guide wire through the screw.The surgery was completed successfully with no surgical delay.No further information is available.This report is for a 4.5mm ti headless compression scr/short thrd/80mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM TI HEADLESS COMPRESSION SCR/SHORT THRD/80MM-STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15138369
• Report Number: 8030965-2022-05447
• Device Sequence Number: 20654553
• Product Code: HWC
• UDI-Device Identifier: 10886982123718
• UDI-Public: (01)10886982123718
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 03/01/2023
• Device Model Number: 04.226.680S
• Device Catalogue Number: 04.226.680S
• Device Lot Number: 8339218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE/COMPRESSION/K-WIRES.; UNK - INSERTION INSTRUMENTS: TRAUMA.
• Patient Age: 17 YR
• Patient Sex: Female