MAUDE Adverse Event Report: DEPUY SPINE INC X-MESH PISTOL INSERTER/EXPANDE; DRIVER, PROSTHESIS

Model Number	288900000
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
(b)(4).The 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 that on an unknown date, broken instrument was found before setting up for surgery.There is no patient involvement.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi:(b)(4).H3: correction.H4, h6: additional information.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.Visual examination revealed that the expansion arms sub assembly was missing a threaded spindle from the expansion threaded bushing.It was noted that the expansion knob mechanism, release lever and pistol grip were damaged and were not functioning as intended.The expansion knob shaft had fractured at its neck.The fracture analysis report reveals plastic deformation at the edges and torsional shear markings following a circular pattern.This suggests the fracture end underwent a quasi-static overload torsional shear failure starting at the edges and extending to the center of the shaft, the potential fracture termination site.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 definitive root cause for the expansion knob shaft becoming fractured cannot be positively determined.However, the fracture analysis report suggests the fracture end underwent a quasi-static overload torsional shear failure starting at the edges and extending to the center of the shaft, the potential fracture termination site.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, 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: X-MESH PISTOL INSERTER/EXPANDE
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9147057
• Report Number: 1526439-2019-52188
• Device Sequence Number: 11418583
• Product Code: HWR
• UDI-Device Identifier: 10705034222592
• UDI-Public: (01)10705034222592
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/11/2019

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: 288900000
• Device Catalogue Number: 288900000
• Device Lot Number: BR1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1