MAUDE Adverse Event Report: SYNTHES GMBH AO REAMING ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.210

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: reporter¿s phone number is not available.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was received fallen apart.The cylindric pin was missing which is crucial for the subassembly¿s function.The long hole from output shaft was showing a small dent.It was determined that the device became damaged when it was twisted, and it should not have been reassembled after initial failure.It was also found that the device failed pre-test for general condition and check the tool coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to the user, which is user error.Review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Udi: (b)(4).Please reference report mwr-24062021-0000985604 as it is related to this medwatch report.

Event Description

It was reported from (b)(6) that during an open reduction internal fixation (orif) surgery for fracture of the proximal femur, when removing a reaming device from the attachment device, the connection of the attachment and a reaming device had come loose because the operation staff slightly twisted the device.It was further reported that the device was twisted back and was able to be used, and the procedure was successfully completed.It was reported that the next day, during cleaning of the device it became loose again, and the parts of the attachment were disassembled into 6 pieces and could not be assembled.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: AO REAMING ATTACHMENT FOR TRS
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 12378758
• MDR Text Key: 268513249
• Report Number: 8030965-2021-07294
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819977891
• UDI-Public: 07611819977891
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1