MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDSLEEVE W/WINGSCR L105 I-0; MISC ORTHO SURGICAL INSTR

Model Number	394.46
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: investigation summary: background: investigation flow: damage.Visual inspection: the holdsleeve w/wingscr l105 i-ø (p/n: 394.460, lot number: 90p0810) was received at us cq.Upon visual inspection of the complaint device showed the wing screw was broken, and the broken fragment was stuck inside the mobile bracket.No other issues were observed with the returned device.Device failure/defect was identified.Dimensional inspection: a dimensional inspection was not performed on the returned device due to post manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint was confirmed.No definitive root cause could be determined based on the provided 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: on 8/27/2021 the lot# 90p0810 correspond to subcomponent art#3742.Part: 3742, lot: 90p0810, manufacturing site: (b)(4), release to warehouse date: 06 april 2021.A manufacturing record evaluation was performed for the subcomponent lot 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.
Event or Problem Description
It was reported on (b)(6) 2021, when disassembling the large distractor, the holding sleeve with wing screw a piece of the wing nut broke off into the sleeve and the other wing nut was cross threaded.The issue was discovered in the sterile processing.There was no patient involvement.Concomitant device reported.Unk - distractor instruments (part# unknown, lot# unknown, qty unknown).This complaint involves two (2) devices.This report is for (1) holdsleeve w/wingscr l105 i-0.This report is 1 of 1 for (b)(4).

• Brand Name: HOLDSLEEVE W/WINGSCR L105 I-0
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12421950
• Report Number: 2939274-2021-05171
• Device Sequence Number: 3609640
• Product Code: LXH
• UDI-Device Identifier: 10886982199744
• UDI-Public: (01)10886982199744
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 394.46
• Device Catalogue Number: 394.460
• Device Lot Number: 90P0810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1