MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SELF-CENTERING BONE FORCEPS 23MM SERRATED JAW-SPEED LOCK

Model Number 398.83

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a synthes sales representative.Without a lot number, the device history records review could not be completed.Product was not returned.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 an unknown date, the self-centering bone forceps broke.It is unknown where, or when the issue was discovered.It is unknown if there was patient involvement.This report is for one (1) self-centering bone forceps 23mm serrated jaw-speed lock this is report 1 of 1 for (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, h4, h6: the self-centering bone forceps 23 mm serrated jaw-speed lock (p/n: 398.83, lot #: a7la08) was returned and received at us cq.Upon visual inspection, the left jaw was observed to be broken.The broken fragment was returned.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.The customer reported the self-centering bone forceps broke.The repair technician reported the device cracked and broke into 2 pieces near the clamping end.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.The complaint condition was confirmed for the self-centering bone forceps 23 mm serrated jaw-speed lock (p/n: 398.83, lot #: a7la08).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.Device history lot null,part number: 398.83, lot number: a7la08, manufacturing site: tuttlingen, release to warehouse date: week 08, 2002.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 18 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.

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.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: SELF-CENTERING BONE FORCEPS 23MM SERRATED JAW-SPEED LOCK
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10663430
• MDR Text Key: 210887115
• Report Number: 2939274-2020-04611
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982201799
• UDI-Public: (01)10886982201799
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 398.83
• Device Catalogue Number: 398.83
• Device Lot Number: A7LA08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 11/06/2020
• Supplement Dates FDA Received: 11/03/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1