MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM TAB BREAKER, CAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	299704315
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
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
On (b)(6) 2017, surgery using the expedium verse system was performed for proximal/distal adjacent kyphosis after the procedure of lumber bursting fracture.The fixed area was t11-s2.During the surgery, the following were confirmed by the surgeon regarding tab breaker body (part#: 299704310, lot#: pu118687) and tab breaker cap (part#: 299704315, lot#: pu115145).The tab breaker could not hold the broken tabs already removed.The broken tabs were falling in the operative field.At the time of breaking a couple of tabs, the tip of tab breaker got broken and dropped from the breaker body.The surgeon successfully removed all the tabs by continuing to use the broken tab breaker.The surgery was completed without any delay, and there was no adverse consequence to the patient.In comparison with the previous complaint per (b)(4), the tab breaker got broken in earlier stage of the procedures.We are required to submit an investigation report based on our manufacturing record and so on.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was received at the investigation site on 11dec2017.Upon inspection, there was no noted malfunction/damage.The device did not cause or contribute to the reported even and as such is considered concomitant.Device is not a reportable malfunction.

• Brand Name: EXPEDIUM TAB BREAKER, CAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7114538
• Report Number: 1526439-2017-50071
• Device Sequence Number: 1874293
• Product Code: LXH
• UDI-Device Identifier: 10705034467368
• UDI-Public: 10705034467368
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2017

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: Health Professional
• Device Catalogue Number: 299704315
• Device Lot Number: PU115145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1