MAUDE Adverse Event Report: DEPUY SPINE INC XPDM DI REDUCTION TUBE; MISC ORTHO SURGICAL INSTR

Model Number	279722460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: not found in spine database.510k: this report is for an unknown mod x25 di tightener/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that the hospital called to report that during spine procedure, a number of instruments on a consignment kit, broke and the hospital discarded items, will be unable to be returned.There was a surgical delay of ten (10) minutes.This complaint involves five (5) devices.This report is for one (1) xpdm di reduction tube.This report is 3 of 5 for (b)(4).

• Brand Name: XPDM DI REDUCTION TUBE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10080630
• Report Number: 1526439-2020-01077
• Device Sequence Number: 14434126
• Product Code: LXH
• UDI-Device Identifier: 10705034199368
• UDI-Public: (01)10705034199368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2020

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: 279722460
• Device Catalogue Number: 279722460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2020
• Initial Report FDA Received Date: 05/21/2020
• Patient Sequence Number: 1