MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE 85MM FOR MEDIUM DISTRACTOR; TRACTION,APPARATUS,NON-POWERED

Model Number	395.46
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is synthes sales consultant.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 during open reduction internal fixation (orif) of ankle surgery on (b)(6) 2019, the wing nut broke on medium distractor sleeve pin and stuck in sleeve.Fragments were generated and removed easily without additional intervention.There was no surgical delay.Procedure was successfully completed.No patient consequence.This report is for one (1) holding sleeve 85mm for medium distractor.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.H3, h4, h6: device history lot part: 395.460, lot: 9319839, manufacturing site: betlach, release to warehouse date: 02.Feb.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The material was reviewed and was confirmed to meet the specification with no non-conformance noted.H3, h6: investigation summary: complaint summary: 03/28/2019: updated event description: it was reported that on (b)(6) 2019, during open reduction internal fixation (orif) of ankle, the wing nut broke on medium distractor sleeve pin and stuck in sleeve.Fragments were generated and removed easily without additional intervention.The schanz screw blunted trocar point was found stripped/worn during an investigation of the device.There was no surgical delay.Procedure was successfully completed.No patient consequence.Flow: broken visual inspection: the holding sleeve 85 mm for medium distractor (part # 395.46, lot # 9319839, mfg # 02-feb-2015) was received at us cq with the wing screw broken off and not returned.This is consistent with the reported complaint condition, thus confirming the complaint.Functional test: a functional test was performed and the schanz screw and the holding sleeve with distractor are stuck together and unable to be disassembled.The complaint was able to be replicated, therefore the complaint is confirmed.Dimensional analysis was not performed as the wing screw was completely broken off and not returned.Document/specification review: the material was reviewed and was confirmed to meet the specification with no non-conformance noted.Conclusion: the complaint condition is confirmed as the holding sleeve 85 mm for medium distractor (part # 395.46, lot # 9319839) was received with the wing screw broken off.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.D4: lot number provided for reporting.H3, h6: the device was received, the investigation completed.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
03/28/2019: updated event description.It was reported that on (b)(6) 2019, during open reduction internal fixation (orif) of ankle, the wing nut broke on medium distractor sleeve pin and stuck in sleeve.Fragments were generated and removed easily without additional intervention.The schanz screw blunted trocar point was found stripped/worn during an investigation of the device.There was no surgical delay.Procedure was successfully completed.No patient consequence.

• Brand Name: HOLDING SLEEVE 85MM FOR MEDIUM DISTRACTOR
• Common Device Name: TRACTION,APPARATUS,NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8404526
• Report Number: 2939274-2019-56881
• Device Sequence Number: 1811050
• Product Code: HST
• UDI-Device Identifier: 10886982200334
• UDI-Public: (01)10886982200334
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: 395.46
• Device Catalogue Number: 395.46
• Device Lot Number: 9319839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1