MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SOCKET WRENCH-11MM WIDTH ACROSS FLATS

Model Number	321.15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.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.
Event or Problem Description
It was reported that on unknown date, products found broken after surgery and are beyond repair.No further information is available.This complaint involves eighteen (18) devices.This report is for (1) socket wrench-11mm width across flats.This report is 6 of 14 for (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.D9.Date device returned to manufacturer.H6 - codes updated to imdrf codes.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the socket wrench-11mm width across flats was missing the cylinder pin between the head and shaft assembly.A dimensional inspection for the socket wrench-11mm width across flats was unable to be performed due to complex geometry of the device.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the socket wrench-11mm width across flats would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.
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.Product complaint # (b)(4).Investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot = > part: 321.150-us.Lot: 54p5544.Manufacturing site: bettlach.Release to warehouse date: 25 may 2020.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device history batch null.Device history review null.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: SOCKET WRENCH-11MM WIDTH ACROSS FLATS
• Common Device Name: WRENCH
• 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: 13196351
• Report Number: 2939274-2022-00069
• Device Sequence Number: 20298808
• Product Code: HXC
• UDI-Device Identifier: 10886982190383
• UDI-Public: (01)10886982190383
• Combination Product (Y/N): N
• 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

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: 321.15
• Device Catalogue Number: 321.15
• Device Lot Number: 54P5544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 02/11/2022; 03/22/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/11/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM FLEXIBLE SHAFT 620MM.; 5.0MM FLEXIBLE SHAFT.; 5.0MM FLEXIBLE SHAFT.; 5.0MM FLEXIBLE SHAFT.; DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T.; DPTH GUGE FOR 2.7MM & SML SCRWS.; GRPC CASE FOR 3.5/4.0MM CMBND CANULD SCRW SET.; GRPHIC CSE FOR 3.5/4.0MM COMBND CANNLTED SCRW SET.; HELICAL BLADE/SCREW COUPLING SCREW.; HOLD-FORCEPS F/SYNREAM REAMING ROD Ø2.5.; HOLDSLEEVE W/WINGSCR L105 I-Ø 6 F/LARGE-.; LARGE QUICK COUPLING.; RATCHET WRENCH-11MM WIDTH ACROSS FLATS.; RATCHTNG HANDL W QUICK CUPLING.; SM FRG LCP INST & IMPL SET GRPIC CASE.; UNIVERSAL CHUCK WITH T-HANDLE.; UNIVERSAL CHUCK WITH T-HANDLE.
• Patient Sex: Unknown