MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/3 HOLES/LEFT; PLATE, FIXATION, BONE

Model Number	02.118.401
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
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 narrative: procode: additional product code: hwc.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Mfr site: postal code: (b)(6).Without a lot number the device history records review could not be completed.Product was not returned.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 australia as follows: it was reported on (b)(6) 2022, that two variable angle locking screws failed to lock into two distal holes in a variable angle lateral clavicle plate.The plate had to be removed and replaced with another which worked as required.User followed ifu.Operating time was extended.Surgery was delayed for 20 minutes.Fragments were not generated.There was patient outcome/ consequences but there was no clinical outcome experienced by the patient.(infection, inflammation.).This report is for one (1) va-lcp lat dist fibula pl 2.7.This is report 1 of 3 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.D10: concomitants added.Therapy date june 30, 2022.Part # 02.118.401, lot # 148p619, manufacturing site: werk selzach, release to warehouse date:12 may 2021, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the event description indicates the impacted product was a variable angle lateral clavicle plate, however, the impacted product received was a va-lcp lat dist fibula pl 2.7 le 3ho l79, p/n: 02.118.401.It was noted that two of the distal va locking holes are stripped.No other problems identified.A dimensional inspection was unable to be performed due to post-manufacturing damage.A functional test was performed, the returned locking screws could not be locked in the holes that exhibit damage on the threads.However, the returned locking screws were successfully locked in the rest of the va locking holes.The complaint condition was replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the va-lcp lat dist fibula pl 2.7 le 3ho l79, p/n: 02.118.401 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.

• Brand Name: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/3 HOLES/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15121122
• Report Number: 8030965-2022-05328
• Device Sequence Number: 12196509
• Product Code: HRS
• UDI-Device Identifier: 10886982038807
• UDI-Public: (01)10886982038807
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120854
• 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 Health Care Professional
• 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: 02.118.401
• Device Catalogue Number: 02.118.401
• Device Lot Number: 148P619
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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: 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP
• Patient Sex: Female