MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH EXTENDED RATCHET

Model Number	SD399.099
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2021, during an orthopedic procedure, the clamp was broken and the surgeon had to use a different clamp.Procedure was completed successfully without any surgical delay.No patient consequences.This report is for (1) reduction forceps with extended ratchet.This is report 1 of 1 for complaint (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.H10 additional narrative: h3, h6: part: sd399.099.Lot: 54p3156.Supplier lot number: n/a.Manufacture date or release to warehouse date: 11/04/2020 expiration date: n/a supplier/manufacture site: (b)(4).No nonconformance reports (ncrs) were generated during production of lot number 54p3156.Review of the device history record (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Dhr review was not performed for component 399.99 of sd399.099.Device 399.99 (lot numbers # t190001 and t198024) were purchased from synthes usa hq, inc.And used to make sd399.099.Visual inspection: the reduction forceps with extended ratchet was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the one of the jaw for forceps is broken at the distal end.The same allegation can be confirmed based on received photo.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection was not performed due to complex geometry of device and post manufacturing defect.Document/specification review: based on the date of manufacture, the following drawings, reflecting the current and manufactured revision were reviewed.Reduction forceps with serrated jaw ratchet.Investigation conclusion: the complaint condition was confirmed for reduction forceps with extended ratchet.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 FORCEPS WITH EXTENDED RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12440726
• Report Number: 2939274-2021-05231
• Device Sequence Number: 14675547
• Product Code: HTD
• UDI-Device Identifier: 10886982007087
• UDI-Public: (01)10886982007087
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: SD399.099
• Device Catalogue Number: SD399.099
• Device Lot Number: 54P3156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR