MAUDE Adverse Event Report: SYNTHES GMBH INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number 03.231.005

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Product code 03.231.005 lot number 7532158 manufacturing site:(b)(4).Release to warehouse date: 22.Aug.2011 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s).The image(s) was reviewed, and the complaint condition could not be confirmed, since the relevant part of the device was not captured in the returned images.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the locking pins that hold the insertion handle of the variable angle locking compression plate (lcp) condylar support had worn thread reliefs, limiting the correct clamping of the plate to apply the percutaneous technique if required.Concomitant devices: unknown insertion handle (part# unknown; lot# unknown; quantity: 1) unknown va-lcp condylar plate (part# unknown; lot# unknown; quantity: 1) this report is for one (1) interlocking bolt for 4.5mm va-lcp condylar insertn handle.This is report 1 of 2 for pc (b)(4).

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: h3, h6: product code 03.231.005.Lot number 7532158.Manufacturing site: hägendorf.Release to warehouse date: august 22, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the bolt f/aiming arm instr f/va-lcp condyla (part #: 03.231.005, lot #: 7532158) was received at us customer quality (cq).Visual inspection of the complaint device showed worn threaded tip.Surface wear was also observed along the shaft of the device.Functional test: a functional assessment was not performed with the complaint device since the applicable mating component(s) were not returned.Also the device exhibited a post manufacturing damage.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the threaded tip was observed to exhibit wear.Surface wear was also observed on the shaft.Moreover, the wear on the thread would impact the way the device assemble with mating device, hence the complaint is confirmed.The failure mode exhibited by the device is consistent with end of life of the device.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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: INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11843557
• MDR Text Key: 252091153
• Report Number: 8030965-2021-04019
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454422
• UDI-Public: 07611819454422
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.231.005
• Device Lot Number: 7532158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOLT F/AIMING ARM INSTR F/VA-LCP CONDYLA; UNKNOWN INSERTION HANDLE; UNKNOWN VA-LCP CONDYLAR PLATE