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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id also reported as (b)(6).Additional procode: lxh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 during surgery for a calcaneus fracture on (b)(6) 2021, the reduction joystick broke.Procedure was completed successfully with a six (6) minute delay.Patient was stable.This report is for a reduction joystick/5.0mm.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: reduction joystick/5.0mm (part# 03.211.454, lot# 7747097, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the distal end of the threaded shaft of the device was broken.The component, centering pin was missing from the assembly.Rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is being confirmed.The complaint is being confirmed for reduction joystick/5.0mm (part# 03.211.454, lot# 7747097) as the distal end of the threaded shaft of the device was broken.While a definitive root cause could not be identified for the reported problem, it is possible that the shaft of the device might have encountered unintended forces.The component might have got misplaced during sterilization.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 upon these results, 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: 03.211.454.Synthes lot number: 7747097.Supplier lot number: n/a.Release to warehouse date: 18jul2014.Expiration date: n/a.Manufactured by synthes jennersville.No ncrs were generated during production.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.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: 11285761
• Report Number: 2939274-2021-00704
• Device Sequence Number: 11723988
• Product Code: HTD
• UDI-Device Identifier: 10886982076465
• UDI-Public: (01)10886982076465
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 01/18/2021

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: 03.211.454
• Device Catalogue Number: 03.211.454
• Device Lot Number: 7747097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 90