MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION JOYSTICK/5.0MM; FORCEPS

Model Number	03.211.454
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: lxh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 an unknown date, during routine incoming inspection of a loaner set, it was observed that the reduction joystick was missing a piece.There was no patient involvement.This report involves one (1) reduction joystick/5.0mm.This is report 1 of 1 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: d10: part returned h3, h4, h6: a review of the device history record.Device history lot part number:03.211.454 synthes lot number: h786283 supplier lot number: n/a release to warehouse date: 21 jun 2019 expiration date: n/a supplier: (b)(4) no ncrs were generated during production.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition h3, h6: investigation summary background: it was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the reduction joystick/5.0mm was missing a piece.There was no patient involvement.This complaint involves one (1) device.Investigation flow: visual visual inspection: the reduction joystick/5.0mm (p/n: 03.211.454, lot number: h786283) was received at us cq.Missing threaded shaft and centering pin.Document/specification review: (current and manufactured) was reviewed.No design issues or discrepancies were identified.Dimensional inspection: dimensional inspections relevant to this complaint were not performed at due to a definitive finding of a missing component.Conclusion: the overall complaint was confirmed for the reduction joystick/5.0mm (p/n: 03.211.454, lot number: h786283) as the threaded shaft and centering pin are missing.These parts are taken apart during cleaning and use.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.No design issues were observed during the document/specification review.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.H11: d4 correction 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: REDUCTION JOYSTICK/5.0MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9957444
• Report Number: 2939274-2020-01819
• Device Sequence Number: 2900711
• Product Code: HTD
• UDI-Device Identifier: 10886982076465
• UDI-Public: (01)10886982076465
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 03.211.454
• Device Catalogue Number: 03.211.454
• Device Lot Number: H786283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1