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

Model Number	04.118.516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
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 synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the osteosynthesis for right clavicular shaft fracture.While grasping the central bone fragment and peripheral bone fragment with bone grasping forceps, the surgeon inserted the screw in question (2.7 mm lwprof metaphys compres screw) into the central bone fragment and then inserted a 2.7 valhs into the peripheral bone fragment.When another 2.7 valhs was inserted into the central bone fragment as the second screw, a plate that had been crimped came up from the central bone fragment, and it was confirmed that the screw in question was broken at its neck.With the shaft of the screw in question remaining in the bone, 4 screws were inserted into the central bone fragment and 5 screws into the peripheral bone fragment, and the surgery was completed with no surgical delay.The surgeon commented as follows.The direct cause of the breakage seemed to be loading on the screw due to the reduction.However, even when a screw with a diameter of 3.5 mm was used in the past similar procedures, breakage like this time did not occur.Therefore, there is concern about a strength of a 2.7 mm lwprof metaphys compres screw.No further information is available.Concomitant device: unk plate (product code: unk, lot number: unk, quantity: unk).Unk screwdriver (product code: unk, lot number: unk, quantity: unk).Unk - screws: 2.7 mm va locking (product code: unk, lot number: unk, quantity: 9).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.H10: additional narrative: d4 h3, h4, h6: part 04.118.516ts, lot 9l11610: manufacturing site: werk selzach.Release to warehouse date: march 04, 2022.Expiration date: march 01, 2027.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): SYNTHES SELZACH; bohackerweg 5; selzach
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 3035526892
• MDR Report Key: 15099200
• Report Number: 8030965-2022-05173
• Device Sequence Number: 17440111
• Product Code: HWC
• UDI-Device Identifier: 10886982108807
• UDI-Public: 10886982108807
• 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: 2022
• 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 Model Number: 04.118.516
• Device Catalogue Number: 04.118.516TS
• Device Lot Number: 9L11610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 69 KG