MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT; MISC ORTHO SURGICAL INSTRUMENT

Model Number	395.921
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 at the time of filing this report.A review of the device history record 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 that on (b)(6) 2019, they used the two (2)threaded drill sleeve-short and two (2) self-drilling schanz screw that were cold welded and fused together during an external fixation.The procedure was completed with a minimum delay to get a chance to get back out of the patient and put the screw in.Patient status is unknown.This complaint involves two (2) devices.This report is 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: event, concomitant medical products.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 noted the procedure was completed successfully.
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.Device history lot: part: 395.921.Lot: 3600967.Manufacturing site: hägendorf.Release to warehouse date: 02.Dec.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: it was reported that on (b)(6) 2019, they used the two (2) threaded drill sleeve-short and two (2) self-drilling schanz screw that were cold welded and fused together during an external fixation.The procedure was completed with a minimum delay to get a chance to get back out of the patient and put the screw in.Patient status is unknown.Flow: device interaction/functional.Visual inspection: the 6.0 mm/ 5.0 mm threaded drill sleeve-short (part # 395.921, lot # 3600967, mfg # 02-dec-2010) was received at us cq with the schanz screw stuck within the drill sleeve.Functional test: a functional test was performed and the schanz screw is stuck within the guide sleeve.The 2 devices could not be separated.This is consistent with the reported complaint condition, thus confirming the complaint.The complaint was able to be replicated since the devices cannot be separated.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.The root cause is that the customer cold welded and fused together the drill sleeve and schanz screw during an external fixation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this 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: 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8669014
• Report Number: 2939274-2019-58466
• Device Sequence Number: 2308670
• Product Code: LXH
• UDI-Device Identifier: 10886982200921
• UDI-Public: (01)10886982200921
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 05/07/2019

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: 395.921
• Device Catalogue Number: 395.921
• Device Lot Number: 3600967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/21/2019; 06/24/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/18/2019; 06/26/2019
• Patient Sequence Number: 1