MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TROCAR HANDLE FOR USE 03.120.014; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.120.015
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2021.Reporter is a j&j employee.The device was received, the investigation is in progress, 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.
Event or Problem Description
It was reported that on an unknown date during an open reduction internal fixation (orif) of the right femur procedure, the trocar handle was not retaining the cannulas for the locking/neutral guide.The locking/neutral guides were also not retaining the aiming arm.The procedure was successfully completed using another locking/neutral guide in the set.There was a surgical delay of (5) minutes.The patient outcome is unknown.This report is for (1) trocar handle for use 03.120.014.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: d4: updated lot number.G1: updated physical manufacturer.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: h4.Investigation summary visual inspection: the complaint device trocar handle (product code: 03.120.015, lot number: 23p7827) was returned to cq west chester for investigation along with locking guides which will be investigated under different ips under subject pc.During visual inspection, the release pin¿s extended tab was found slightly bent.Also, the picture of the device was reviewed and the findings were consistent with physical device investigation.Functional test: during functional test, the trocar handle could not hold any of the 3 returned locking/neutral guide.This could be due to the bent nature of the release spring.Can the complaint be replicated with the returned device(s)? yes, the complaint condition can be replicated during functional test.Complaint confirmed: yes, the complaint condition can be confirmed during physical device investigation.Conclusion: the insertion handle had slight damage to the release spring assembly due to which it was not able to retain the guide in place, hence the complaint was not confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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 number: 03.120.015 lot number: 23p7827 manufacturing site: haegendorf release to warehouse date: 13 november 2019 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: h3, h6.

• Brand Name: TROCAR HANDLE FOR USE 03.120.014
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12722274
• Report Number: 2939274-2021-06383
• Device Sequence Number: 14460041
• Product Code: FZX
• UDI-Device Identifier: 10886982074133
• UDI-Public: 10886982074133
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2021

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: 03.120.015
• Device Catalogue Number: 03.120.015
• Device Lot Number: 23P7827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/28/2021; 11/17/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/01/2021; 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; LCK/NEUT GD 4.5 VA LCP CRVD COND AIM ARM; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - PLATES: LCP CONDYLAR
• Patient Sex: Unknown