MAUDE Adverse Event Report: SYNTHES GMBH HUDSON REDUCTION DRIVE UNIT; DRIVER, SURGICAL, PIN

Catalog Number	532.018
Medical Device Problem Codes	Device-Device Incompatibility (2919); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional 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.Concomitant med products and therapy dates: small battery drive device, (b)(6) 2021.The initial reporter's phone numbe was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during surgery for a femoral fracture, it was discovered that the reduction drive device failed to lock onto the handpiece device and fell out easily.It was further reported that the surgeon continued to use the unlocked devices to complete the surgery without any surgical delay.It was noted that another attachment device was attached to the handpiece device without issue and the problem seemed to be with the reduction drive device.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.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.H6: device history review: a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.Device evaluation: the actual device was returned for evaluation.During repair, the device was functionally and visually tested by quality engineering and it was determined that it was possible to pull out the attachment from the gauge without releasing the gauge and furthermore the device showed signs of slight corrosion on the outer surface.It was further determined that the device coupling dimensions were out of specification.It was further determined that the locking groove had not been manufactured according to specifications hence the holding edge was not as steep as it should have been and therefore the attachment could not be properly locked to the handpiece coupling.It was determined that this defect was caused by the machining tool and is being further investigated and assessed under a capa.It was further determined that the device failed pretest for general condition and check the machine coupling.Therefore, the reported condition was confirmed.The assignable root cause for the device failing to lock and falling out easily was determined to be due to manufacturing and the assignable root cause for corrosion of the device was not established.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: HUDSON REDUCTION DRIVE UNIT
• Common Device Name: DRIVER, SURGICAL, PIN
• 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: 12167196
• Report Number: 8030965-2021-05664
• Device Sequence Number: 4199266
• Product Code: GFC
• UDI-Device Identifier: 07611819118881
• UDI-Public: 07611819118881
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 532.018
• Device Lot Number: MA10033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/19/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 11/11/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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: Unknown