MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE HOOK-SHAPE ARM 206MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	398.756
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: upon visual inspection no damage was noted on the instrument that would contribute to the complaint condition.Functional test: a functional test was performed and the arm release button was seized which would prevent the attachments from interacting properly with this instrument and this the complaint is confirmed.Dimensional inspection: no dimensional inspection was performed as relevant dimensions could not be accessed without damaging the instrument.Document/ specification review: based on the review of the relevant drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: the complaint condition was confirmed for the instrument.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part: 398.756, lot: 09-5791.Manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 01.March 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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 that on unknown date, during inspection at sterile processing department (spd), a collinear clamp (sliding mechanism) and bone hook-shape arm do not attach properly.They are not sure which instrument is broken.There was no surgical procedure and patient involvement.This report is for one (1) bone hook-shape arm 206mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: BONE HOOK-SHAPE ARM 206MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11605220
• Report Number: 2939274-2021-01662
• Device Sequence Number: 11813742
• Product Code: LXH
• UDI-Device Identifier: 10886982201591
• UDI-Public: (01)10886982201591
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 02/10/2021

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: 398.756
• Device Catalogue Number: 398.756
• Device Lot Number: 09-5791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1