MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NUT INTRLCK BOLT VA LCP COND INSRTN HNDL; SCREW,FIXATION,BONE

Model Number	03.231.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, during sterilization process of a routine field inspection, the bolt does not tighten onto instrument.There was no patient involvement.This complaint involves one (1) device.This report is for (1) nut intrlck bolt va lcp cond insrtn hndl.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
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: updated data: d4, h4.Investigation summary visual inspection: the complaint device (locknut f/aiming arm instr f/va-lcp cond) was returned for investigation.The reported condition is not confirmed as the nut appears to be in good condition with no signs of defect or failure.Device failure/defect identified? no.Functional test: the mating device (03.231.005 - bolt f/aiming arm instr f/va-lcp condyla) was not returned for analysis, therefore a functional test was not performed.Document/specification review: the current and manufactured versions of drawing were reviewed.Complaint confirmed: no, the complaint cannot be confirmed based on the available information.Investigation conclusion: the reported condition of the complaint device (locknut f/aiming arm instr f/va-lcp cond) is not confirmed.No problem was found within the device.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 history lot: part # 03.231.006.Lot # 3747702.Release to warehouse date: 05 may 2011.Manufacturer: hagendorf.No ncr's were generated during production.A manufacturing record evaluation was performed for the finished device lot number, 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.Corrected data: d9, h3, h6.

• Brand Name: NUT INTRLCK BOLT VA LCP COND INSRTN HNDL
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12927185
• Report Number: 2939274-2021-06958
• Device Sequence Number: 20073174
• Product Code: HWC
• UDI-Device Identifier: 10886982077332
• UDI-Public: (01)10886982077332
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2021

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: 03.231.006
• Device Catalogue Number: 03.231.006
• Device Lot Number: 3747702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown