MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM; PLATE, FIXATION, BONE

Model Number	02.107.202
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
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.Additional procode: hwc.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 australia reports an event as follows: it was reported that on (b)(6) 2022, orif of right olecranon was being performed as a revision procedure due to the patient experiencing a fall.While implanting a va-lcp olecranon plate, the surgeon found that the two most proximal va holes would not engage with the locking screw.The screw would just spin in place.The plate was swapped out for another of the same model, and the issue persisted.All instruments were used according to the technique guide.This report is for a 2.7mm/3.5mm va-lcp olecranon pl 2h/rt/90mm.This is report 2 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, h3, h4, h6: part 02.107.202, lot 98p5663: manufacturing site: werk selzach.Supplier: synthes usa hq, inc.Release to warehouse date: april 01, 2021.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that there was no damage or defects with the plate.A dimensional inspection was performed and met specifications.A functional test was performed, the assemble issue is due to the threads in the head of another plate has stripped.The hole diameter of the implant was verified.The current and manufactured drawing was reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the plate was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.
Event or Problem Description
It was noted the procedure was completed successfully with a twenty to thirty (20-30) minute delay.
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: d4, h4: the lot number and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/90MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15147340
• Report Number: 8030965-2022-05489
• Device Sequence Number: 12215392
• Product Code: HRS
• UDI-Device Identifier: 10886982029263
• UDI-Public: (01)10886982029263
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120070
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 02.107.202
• Device Catalogue Number: 02.107.202
• Device Lot Number: 98P5663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 09/05/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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 - SCREWS: LOCKING; VA-LCP OLECR PL 2.7/3.5 R 4HO L116 SST; VA-LCP OLECR PL 2.7/3.5 R 4HO L116 SST
• Patient Sex: Unknown