MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WIRE TIGHTENER WITH HANDLE & TWO PEGS 240MM; MISC ORTHO SURGICAL INSTR

Model Number	391.21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact date of event is unknown; event reportedly occurred in 2019.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 or Problem Description
It was reported that on an unknown date in 2019, during orthopedic procedure, handle of wire tightener with handle broke.Fragments were generated and removed easily without additional intervention.There was no surgical delay.Procedure was successfully completed with no patient consequence.This report is for one (1) wire tightener with handle & two pegs 240mm.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.H10 additional narrative: h3, h6: device history record (dhr) is not available as the device is older than 21 years.At this time, the manufacturing documents for instruments had to be stored for 10 years.This was according to policy, which was in place till august 2014.Last documented lot is lot 2092 made in march 1998.Service and repair evaluation: the customer reported that the wire tightener with handle & two pegs 240mm was broken.The repair technician reported that the handle was broken into two pieces.Broken handle 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 (cq).The evaluation was confirmed.Visual inspection: the wire tightener with handle & two pegs 240 mm (part 391.21, lot 2041) was received at us cq with the bottom half of the handle broken into 2 pieces.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed.Document/specification review: the following drawings were reviewed: wire tightener, 230 mm and drahtspanner.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative 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.
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: d4, e3, g3: additional information provided.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H11 corrected data: d10, h3.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: WIRE TIGHTENER WITH HANDLE & TWO PEGS 240MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8403957
• Report Number: 2939274-2019-56880
• Device Sequence Number: 2326139
• Product Code: LXH
• UDI-Device Identifier: 10886982198228
• UDI-Public: (01)10886982198228
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2019

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: 391.21
• Device Catalogue Number: 391.21
• Device Lot Number: 2041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/15/2019; 04/19/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/05/2019; 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR