MAUDE Adverse Event Report: DEPUY SPINE INC MOD ROD ROTATION TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	698342872
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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 instrument broke during procedure.No delay in case or harm to patient.Standard rod holder was used to complete case.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the mod rod rotation tool revealed significant indentation marks indicating extensive wear during its filed usage.It was also noted that saddle was missing from the tip of the locking shaft with the tip slightly worn-out likely due to unanticipated forces during use.No other anomalies were identified during device evaluation.A dhr review could not be performed the product code 698342872, lot #: dp0218, although repeated attempts have been made to locate the lot.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for falling apart of the mod rod rotation tool cannot be determined from the information provided.However, a potential root cause may likely be that the tip of the shaft must have been attributed to unanticipated torsional forces during tightening, resulting in saddle falling apart.As no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MOD ROD ROTATION TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7361682
• Report Number: 1526439-2018-50270
• Device Sequence Number: 1052328
• Product Code: LXH
• UDI-Device Identifier: 10705034494104
• UDI-Public: (01)10705034494104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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 Model Number: 698342872
• Device Catalogue Number: 698342872
• Device Lot Number: DP0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR