MAUDE Adverse Event Report: SYNTHES GMBH TORQUE LIMITING ATTACHMENT 4NM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	511.771
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Initial reporter¿s mailing address and phone number where not available; however the sales representatives name and email were provided as (b)(6).The device serial or lot number was unknown.The manufacturing site name and address were unknown due to unknown serial number.Device manufacture date was unknown.Udi: the device serial or lot number was unknown; therefore, udi: (b)(4).Concomitant med products and therapy dates: drill bit device and screw driver device; (b)(6) 2021.Please note: mwr- (b)(4) is related to medwatch reports mwr-(b)(4) ; mwr- (b)(4); mwr-(b)(4) as the products were used together in the same event.
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was observed that the torque limiting attachment device was locked making it impossible to lock and tighten screws with it.It was further reported that the tips of the screws tightening wrenches, also did not fit due to the device being locked.According to the reporter, this made it impossible to properly insert the locking screws.It was noted that the drill bits were blunt and crooked which lead to longer surgery time.It was reported that there was an increase in surgical time of one hour and there was ligament injury to the patient.It was not reported whether a spare device was available for use.There was patient involvement.There were no reports of prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: TORQUE LIMITING ATTACHMENT 4NM
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12184901
• Report Number: 8030965-2021-05654
• Device Sequence Number: 11587917
• Product Code: GEY
• UDI-Device Identifier: 07611819119376
• UDI-Public: 07611819119376
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 511.771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR