MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER SHAFT 2 W/HOLD-SLEEVE L66; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	314.676
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
Device report from depuy synthes reports an event in japan as follows: this is report 3 of 3 for (b)(4).It was reported by the customer in japan that on (b)(6) 2022, a patient underwent the open reduction internal fixation surgery using the lcp plate for fracture of distal end of radio-ulna with the drill sleeve and the screwdriver shaft in question.According to the report, the surgeon had difficulty in wearing the drill sleeve when using the plate, and it took time in all holes.It was further reported that it was difficult to insert the screw because the screw could not be attached vertically to the screwdriver shaft.It was reported that by changing the screwdriver shaft to the short one, it was successfully inserted without any problem.It was reported that due to these events, the operation scheduled for 2 hours was extended to 3 hours.It was reported that the surgery was completed successfully.It was reported that anesthesiologists warned the surgeons that a 3-hour operation was a high-risk procedure for patients in their 90s.The surgeon understood that the product was difficult to operate due to the influence of blood adhesion and the thinness of the plate.No further information is available.This complaint involves three (3) devices.

• Brand Name: SCRDRIVER SHAFT 2 W/HOLD-SLEEVE L66
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14501444
• Report Number: 8030965-2022-03527
• Device Sequence Number: 20114600
• Product Code: HXX
• UDI-Device Identifier: 07611819771314
• UDI-Public: 07611819771314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 314.676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Female