MAUDE Adverse Event Report: SYNTHES GMBH LARGE CHUCK WITH KEY DRILLING SPEED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.253
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is event 1 of 2 of the same event it was reported from france that during an unspecified surgical procedure, it was observed that the while in use with the large chuck with key device and the quick coupling device the spindle chuck was spinning when it should not have been and the handle was misaligned.This caused the surgeon to injure the finger.The device was used with the small battery drive device and two quick coupling devices.According to the reporter there were no issues with the small battery drive device.There was an unspecified delay in the surgical procedure.A spare small battery drive device and quick coupling device were used to complete the procedure.There was patient involvement.There are no updates so far on the surgeon's health.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.Concomitant devices: small battery drive device, 2 quick coupling devices, therapy date: 9/1/2022 udi: (b)(4).
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.B5: event description: during further follow up with the reporter it was reported that the device stubbed his finger.The physician had a blood exposure accident and a finger pulp wound which required medical intervention.The surgeon continued the operation despite the injury in order to prevent loss of the patient but the surgeon's concentration was no longer one hundred percent.The surgeon waited until the end of the procedure to take care of the finger injury.According to the reporter the broach device with the small battery drive device was misaligned.H10: the actual device was returned for evaluation.The device was evaluated and it was determined that the reported condition was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device was not functioning properly and the color ring was not visible anymore it was chipping.The device also failed pretests for general condition, drill chuck function and drill chuck in smallest range.The assignable root cause was traced to improper maintenance.A review of the service history record indicates that the device had not been returned previously for the same malfunction.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.B5: during further follow up with the customer, it was reported that after the doctor's finger was injured the surgeons blood was exposed to the patient's blood.According to the reporter serolological samples were taken from the patient.It was unknown exactly what kind of wound the surgeon had.It was unknown how the patient was affected by the event.

• Brand Name: LARGE CHUCK WITH KEY DRILLING SPEED
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 15469845
• Report Number: 8030965-2022-06875
• Device Sequence Number: 17260447
• Product Code: HWE
• UDI-Device Identifier: 07611819979734
• UDI-Public: 07611819979734
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2022

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: 05.001.253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 10/18/2022; 11/17/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/14/2022; 10/20/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown