MAUDE Adverse Event Report: DEPUY SPINE INC BALL TIP FEELER CURVED; PROBE

Model Number	275010160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2019
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, during the surgery, an instrument broke.The procedure and patient outcome were unknown.Surgical delay is unknown.This complaint involves one (1) device.
Additional Manufacturer Narrative
(b)(4).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.The device¿s distal tip was broken off, no fragments were returned.The device broke approximately 30mm from the tip.There were light surface scratches along the handle of the device consistent with normal wear.The color ring was slightly discolored.The received condition was consistent with the complaint condition thus the complaint was confirmed.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.Although no definitive root-cause can be determined it is possible the device experienced unintended forces during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.

• Brand Name: BALL TIP FEELER CURVED
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9219310
• Report Number: 1526439-2019-52273
• Device Sequence Number: 2852490
• Product Code: HXB
• UDI-Device Identifier: 10705034194073
• UDI-Public: (01)10705034194073
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/25/2019

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: 275010160
• Device Catalogue Number: 275010160
• Device Lot Number: TY18048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1