MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROVISIONAL TENSIONING DEVICE; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	391.884
Medical Device Problem Code	Break (1069)
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, as no product was received.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an orthopedic procedure.The two (2) springs were discovered to be broken preoperatively and were removed from the provisional tensioning device.It is unknown if there was a surgical delay.The procedure outcome and patient status were unknown.This complaint involves two (2) devices.This report is 2 or 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.Device history lot: part number: 391.884.Synthes lot number: p305798.Supplier lot number: p305798.Release to warehouse date: 03-mar-2004.Manufacturing site: synthes monument.Supplier: pioneer surgical technologies.No ncrs were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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.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: PROVISIONAL TENSIONING DEVICE
• 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: 8418859
• Report Number: 2939274-2019-56948
• Device Sequence Number: 13914763
• Product Code: LXH
• UDI-Device Identifier: 07611819719859
• UDI-Public: (01)07611819719859
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2019

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 Catalogue Number: 391.884
• Device Lot Number: P305798
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 05/14/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/14/2019; 05/15/2019
• Patient Sequence Number: 1