MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 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	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that the surgeon found that the tab breaker (p/n: 299704310 ) tip was broken during the surgery preparation (before sterilization) on (b)(6) 2018.The broken device will not be used for the surgery.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # (b)(4).Further review of the complaint determined that the device did not cause or contribute to the breakage of the tab breaker tip.As such, the device is considered concomitant and non-reportable.No further follow up is anticipated.

• Brand Name: EXPEDIUM TAB BREAKER, CAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8261783
• Report Number: 1526439-2019-51245
• Device Sequence Number: 18877821
• Product Code: LXH
• UDI-Device Identifier: 10705034467368
• UDI-Public: 10705034467368
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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 Catalogue Number: 299704315
• Device Lot Number: PU118688
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1