MAUDE Adverse Event Report: SYNTHES TUTTLINGEN OSTEOTOME STRAIGHT/12MM WIDTH

Catalog Number 389.72

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Device is an instrument and is not implanted/explanted.Manufacturing date: december 07, 2015.Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.All parts were checked for function at the final inspection.The raw material is corresponding to the specifications.No non-conformance reports were generated during production.A product investigation was completed: the returned devices were examined and the complaint conditions were able to be confirmed as the osteotome handle was found to be rotated.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The returned instrument was examined and the complaint condition was able to be confirmed as device shaft was found to be rotated approximately 45 degrees in relation to the device handle in a manner consistent with a broken pin.No definitive root cause was able to be determined however the application of torsional forces causing the pin failure is likely.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

Event Description

On (b)(6) 2016, the surgeon performed a l5-s1 anterior discectomy and fusion (alif).During the surgery, when the surgeon used the osteotome, the handle rotated on the shaft of the instrument.The internal pin which secures the handle to the shaft of instrument may be broken or loose from the main instrument.A back up part was available for use and there was a minimal surgical delay.The surgery was successfully completed.No harm to patient from the two instrument failures.There was a total of a two minute surgical delay.When the device was evaluated by the manufacturer, it was noted that the handle was rotated in a manner that is consistent with a broken pin.This is report 1 of 1 for (b)(4).

• Brand Name: OSTEOTOME STRAIGHT/12MM WIDTH
• Type of Device: OSTEOTOME
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5653033
• MDR Text Key: 45126829
• Report Number: 9680938-2016-10071
• Device Sequence Number: 1
• Product Code: HWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 389.72
• Device Lot Number: T130475
• Other Device ID Number: (01)10705034776347(10)T130475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• 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