MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE; CONDYLAR PLATE FIXATION IMPLANT

Model Number 03.231.005

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Event Description

It was reported that on an unknown date, the interlocking bolt for 4.5mm va lcp curved condylar plate insertion handle threads are not properly seated with plates.The procedure outcomes were unknown.No patient consequence.This report is for one (1) interlocking bolt for 4.5mm va-lcp condylar insertn handle.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.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.

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.Lot: 85p6163, manufacturing site: haegendorf, release to warehouse date: march 01, 2021, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the interlckng bolt 4.5 va cond insertn hndl was received at pal jrz.Upon visual inspection of the physical product, the complaint description cannot be confirmed.Light scratches on the shaft and threads were observed under microscope which were consistent with the field usage, but not enough that would impact the functionality of the device, see attached files.No other issues were identified with the device.Functional test: a complete functional test could not be performed as the device was returned by itself.Dimensional inspection: measured dimensions: shaft ø: conforming inner ø: conforming document/specification review: drawing, manufactured and current.No design issues or discrepancies were identified.Investigation conclusion: the complaint cannot be confirmed for interlckng bolt 4.5 va cond insertn hndl.The complaint condition is not confirmed as the device was received with no defect founds.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 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 Description

It was further reported that the issue was discovered while trying to attach to the jig.

• Brand Name: INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13254406
• MDR Text Key: 292059688
• Report Number: 2939274-2022-00168
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982077325
• UDI-Public: (01)10886982077325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.005
• Device Catalogue Number: 03.231.005
• Device Lot Number: 85P6163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE.