MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MODIFIED INSTRUMENT; DRIVER, PROSTHESIS

Catalog Number	698327060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.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
Rep left voicemail.Instrument broke during surgery.The screwdriver tip broke off when the surgeon was provisionally tightening the set screw.The tip was retrieved from the womb and delivered to sterile processing to be cleaned along with the driver.However, the tip was lost during the cleaning process.
Additional Manufacturer Narrative
The inserter was returned with its tip broken off.The tip fragment was not returned for evaluation.The inserter was subsequently submitted for fracture analysis.Optical imaging of the inserter¿s fracture surfaces show torsional shear markings following a circular pattern indicating torsional overload.No material defects of other abnormalities were observed in this analysis.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the driver tip breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is torsional shear failure due to unexpectedly high forces placed on the inserter during tightening.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and 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: MODIFIED INSTRUMENT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6966055
• Report Number: 1526439-2017-10880
• Device Sequence Number: 1483540
• Product Code: HWR
• UDI-Device Identifier: 10705034230665
• UDI-Public: (01)10705034230665
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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: Physician
• Device Catalogue Number: 698327060
• Device Lot Number: WA14227A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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