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

Catalog Number 05.001.253

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/07/2021

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.The initial reporter's phone number was not available.Device evaluation: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during a distal radius surgery, it was discovered that some metal balls dropped from the chuck device.It was reported that there was a ten minute delay to the surgical procedure.It was further reported that the metal balls were removed from the operated site and the surgery was successfully completed.It was reported that fragments were generated and they were removed easily without additional intervention.It was not reported if a spare device was available for use.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.

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.B5: event description: upon subsequent follow-up with the customer, additional information was received.The reporter clarified, that the surgeon used a spare device to complete the surgery.And also cleaned the surgical site.The reporter further clarified, that no post-surgical intervention or treatment was required, due to this event.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed.And it was determined, that the device did not function and had component damage.It was further determined, that the device failed pretest for check the drill chuck and check function of tool coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined, to be due to component failure from wear.

• Brand Name: LARGE CHUCK WITH KEY DRILLING SPEED
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/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: 12828559
• MDR Text Key: 280883607
• Report Number: 8030965-2021-09576
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819979734
• UDI-Public: 07611819979734
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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