MAUDE Adverse Event Report: SYNTHES BETTLACH BURR ACORN-SHAPED L Ø 6.0MM HEAD LENGTH 8.0MM; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number 03.000.062S

Device Problem Failure to Run on Battery (1466)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a case an electronic pen console would only work in reverse and a burr attachment would not spin at all.The sets were booked for a hip revision case to burr out cement to prevent a femur fracture during cement removal.During the case, the pen driver would only work in reverse and not forward.The console would light up but the pen drive would not make any noise.In both reverse and forward the burr would not spin in the burr attachment.While trying to remove cement with rasps, the femur cracked so another treatment option was used to finish the procedure.The procedure was delayed by forty-five minutes.(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Manufacturer Narrative

Upon further review of this complaint, it was determined that the reported event was incorrectly filed as a serious injury.Based on the review, it was determined that the serious injury was caused by the competitor's device.Synthes devices were not in use at the time the serious injury occurred.Therefore, the reported event has been updated from a serious injury to a device malfunction.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BURR ACORN-SHAPED L Ø 6.0MM HEAD LENGTH 8.0MM
• Type of Device: INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3890863
• MDR Text Key: 21804523
• Report Number: 9612488-2014-10240
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 03.000.062S
• Device Lot Number: 7737923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2012
• 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
• Patient Outcome(s): Required Intervention