MAUDE Adverse Event Report: SYNTHES MONUMENT 3.8MM DRILL BIT WITH 20MM STOPQC; BIT,DRILL

Catalog Number	03.161.055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.A device history record (dhr) review for part # 03.161.055 lot # pe02347: release to warehouse date: 11-august-2015, expiration date: n/a, supplier: (b)(4).No non conformance reports (ncrs) were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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.
Event or Problem Description
The service and repair department documented that synthes evaluation equipment-both items broken.Issue identified during inspection activities of the evaluation set.There were no issues reported by the customer.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: a visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint regarding broken devices is not confirmed or replicated; however the devices being stuck together was confirmed during investigation.No non-conformance reports were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The returned devices were found to be stuck together.The sleeve on the handle is able to translate back and forth, however the drill bit does not release.There are some scratches on the handle and drill bit which appear to be from attempts to separate the devices.Neither device is broken as stated in the complaint condition; however, the condition of the devices being stuck together was confirmed during investigation.The returned devices are part of the antegra instrument and implant set.The relevant drawings were reviewed during investigation.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.As the devices are unable to be separated, measurements are unable to be taken.The devices likely experienced excessive torque during use which may have led to damage to the coupling portions of the devices.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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.
Event or Problem Description
It was confirmed that the instruments (drill bit and handle for quick coupling) were not used in a procedure.It is unknown when the devices became stuck together.

• Brand Name: 3.8MM DRILL BIT WITH 20MM STOPQC
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6380911
• Report Number: 1719045-2017-10189
• Device Sequence Number: 13585327
• Product Code: HTW
• UDI-Device Identifier: 10705034711713
• UDI-Public: (01)10705034711713(10)PE02347
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

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: 03.161.055
• Device Lot Number: PE02347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1