MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. OUTERSLEEVE F/PERCUTANEOUS LCP AIMING IN; GAUGE, DEPTH

Catalog Number	03.113.009
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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
It was reported that on (b)(6) 2021, the patient underwent a orif distal tibia procedure.The surgeon noticed that the sleeves were loose in the aiming arm.After inspection, all three sleeves with the same lot number were loose in the aiming arm while others fit well.Procedure was completed successfully without any surgical delay.Concomitant devices reported: unk: guides/sleeves/aiming: aiming arm(part# unknown, lot# unknown, quantity# 1).This report is for one (1) outer sleeve f/3.5mm lcp percutaneous instrument system.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: part: 03.113.009-us; lot: 3455260; manufacturing site: hagendorf; release to warehouse date: august 3, 2010.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the outersleeve f/percutaneous lcp aiming in (part# 03.113.009, lot# 3455260 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, no issues were found with the device.Functional test: a functional test could not be performed as the mating device was not returned.Can the complaint be replicated with the returned device(s)? unable to perform dimensional inspection: outersleeve body, manufactured revision; outer diameter (a) specification; outer diameter (a) actual: conforming; caliper.Outersleeve tube, manufactured; inner diameter (a) specification; inner diameter (a) actual: conforming; caliper.Document/specification review: the following drawing(s) was reviewed: outersleeve f/perc lcp ins.Guide: current and manufactured revisions.Outersleeve body, current and manufactured revisions.Outersleeve tube, current and manufactured revisions.No design issues or discrepancies were found during this investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for the outersleeve f/percutaneous lcp aiming in (part# 03.113.009, lot# 3455260 qty# 1).A definitive root cause could not be identified for the reported issue with the available information.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 upon these results, 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: OUTERSLEEVE F/PERCUTANEOUS LCP AIMING IN
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• MDR Report Key: 12516271
• Report Number: 3006356043-2021-00003
• Device Sequence Number: 5121975
• Product Code: HTJ
• UDI-Device Identifier: 07611819334366
• UDI-Public: (01)07611819334366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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 Catalogue Number: 03.113.009
• Device Lot Number: 3455260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OUTERSLEEVE F/PERCUTANEOUS LCP AIMING IN.; OUTERSLEEVE F/PERCUTANEOUS LCP AIMING IN.; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM.
• Patient Age: 66 YR
• Patient Weight: 63