MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13MM PROTECTION SLEEVE-SHORT; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.229
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.A review of the device history records has been requested.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 on (b)(6) 2018, a cannulated drill bit became stuck in the guide sleeve and would not rotate during an unknown procedure.Both items were removed from the surgery.The nurse took them back to sterile processing to be cleaned by the technician.After cleaning, the drill bit was still stuck and not rotating.There was no surgical delay reported.Patient and procedure outcome are unknown.This report is for one (1) 13mm protection sleeve-short.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
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.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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.Dhr review was completed.Part: 03.010.229.Lot: l310398.Manufacturing site: haegendorf.Release to warehouse date: 23.Feb.2017.The device history record shows this lot of 6 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Investigation flow:functional: visual inspection: visual inspection confirmed the reported complaint condition as the device was returned stuck with its mating device.The device could not be disassembled.No further issues were identified.The complaint condition replication and functional inspection is not possible due to the device returned in stuck condition.The received condition does agree with the complaint description.The complaint is confirmed.Dimensional inspection: 13 mm protection sleeve (top level) - (current and manufactured).13 mm protection sleeve - (current and manufactured) were reviewed during the investigation and no design issues were identified.Dimensional analysis of the relevant portions could not be performed due to post manufacture stuck condition.Relevant portions were not accessible for measurement due to stuck condition.Document/specification review: review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Conclusion: no definitive root cause could be determined from the provided information, however during visual inspection a very slight off-axis insertion of drill with protection sleeve was observed.Therefore, it is possible that any off-axis alignment could have likely contributed to the complaint condition.The complaint is confirmed.However, no design or manufacturing defect or deficiency was observed during the investigation.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.

• Brand Name: 13MM PROTECTION SLEEVE-SHORT
• 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: 8069543
• Report Number: 2939274-2018-54972
• Device Sequence Number: 16558619
• Product Code: LXH
• UDI-Device Identifier: 10886982068118
• UDI-Public: (01)10886982068118
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 10/29/2018

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 Catalogue Number: 03.010.229
• Device Lot Number: L310398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 11/20/2018; 12/19/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 11/19/2018; 12/10/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR