MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERIARTICULAR REDUCTION FORCEPS-MEDIUM

Model Number	398.226
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the periarticular reduction forceps-medium (p/n: 398.226, lot #: a7na11) was returned and received at us cq.Upon visual inspection, it was observed that the pivot screw was received disassembled from the device and the stake to hold the pivot screw in place was broken.There were scratches and the etch on the device started to fade but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: during functional test, the pivot screw was able to be assembled on to the device but was able to disassembled due to broken stake.Dimensional inspection: a dimensional inspection was not performed due to post manufacturing defect.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The stake of the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the periarticular reduction forceps-medium (p/n: 398.226, lot #: a7na11).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.A device history record (dhr) review was conducted: part number: 398.226, lot number: a7na11, manufacturing site: (b)(4), release to warehouse date: week 11, 2004.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 17 years old).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 by the sterile processing department that the spin wheel on the periarticular clamp was no longer spinning smoothly.No patient involvement.During manufacturer's investigation of the returned device it was observed that the pivot screw was received disassembled from the device and the stake to hold the pivot screw in place was broken.This report is for one (1) periarticular reduction forceps-medium.This is report 1 of 1 for (b)(4).

• Brand Name: PERIARTICULAR REDUCTION FORCEPS-MEDIUM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11842080
• Report Number: 2939274-2021-02408
• Device Sequence Number: 4016930
• Product Code: HTD
• UDI-Device Identifier: 10886982201317
• UDI-Public: (01)10886982201317
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/22/2021

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: 398.226
• Device Catalogue Number: 398.226
• Device Lot Number: A7NA11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1