MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH QUICK CONNECT T27 POLY DRIVER; DRIVER, PROSTHESIS

Model Number	279704400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) 2018, the surgery for pelvic fracture was performed using the expedium system.During the surgery, after tapping was completed, the tip of the reported device ((b)(4)) got broken during use.The surgeon replaced the device in question with another one and successfully completed the surgery.No broken pieces were found left in the patient¿s body, and there was no adverse consequence to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Device was received at the investigation site.It was noted that the tip was stripped.If the device functional issue were to recur, other drivers of the same product code or alternate drivers with the same tip configuration would be readily available in the kit to complete the case without issue.As such, this is now a non-reportable malfunction.

• Brand Name: QUICK CONNECT T27 POLY DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7508332
• Report Number: 1526439-2018-50463
• Device Sequence Number: 19125002
• Product Code: HWR
• UDI-Device Identifier: 10705034301280
• UDI-Public: (01)10705034301280
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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 Model Number: 279704400
• Device Catalogue Number: 279704400
• Device Lot Number: MI40810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR