MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RED FORCEPS POINTS NARROW-RATCHET 132

Model Number 398.40

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that on (b)(6) 2021, during the procedure the reduction forceps tip broke off in the bone and fragments were generated.The surgeon decided it would be better to leave the piece in the bone and not digging it out.Procedure was completed successfully with no surgical delay.This report is for one (1) reduction forceps with points narrow-ratchet 132mm.This is report 1 of 1 for complaint (b)(4).

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.H3, h6: part number: 398.40, lot number: a7oa14, manufacturing site: tuttlingen, release to warehouse date: week 14, 2005.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 16 years old).Visual inspection: the reduction forceps with points narrow-ratchet 132mm (part#: 398.40, lot#: a7oa14) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that one of the jaws of the device got broken.There was some discoloration around the etch on the device.The embedded piece cannot be confirmed as there was no evidence (photos or x-rays) provided showing that the fragments were embedded in the patient.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the relevant features of the received device was not performed at cq due to post manufacturing damage.Document/specification review the following document(s) was reviewed: reduction forceps, length 131 (current).Reduction forceps with points (manufactured).Complaint confirmed? yes.Investigation conclusion: the complaint is confirmed for reduction forceps with points narrow-ratchet 132mm (part#: 398.40, lot#: t974043) as one of the jaws of the device got broken.However, the embedded device allegation was not confirmed as there were no photos or x-rays provided.While a definitive root cause could not be identified for the reported problem, it is possible that the jaw of the device might have encountered unintended forces.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 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: RED FORCEPS POINTS NARROW-RATCHET 132
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11840464
• MDR Text Key: 251103401
• Report Number: 2939274-2021-02397
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982201355
• UDI-Public: (01)10886982201355
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 398.40
• Device Catalogue Number: 398.40
• Device Lot Number: A70A14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention