MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Material Fragmentation (1261)

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

Event Date 10/28/2015

Event Type  malfunction  

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.Dhr review ¿ manufacturing site: (b)(4).Manufacturing date: 04.Jan.2008.No ncrs were generated during production.Review of the device history record 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.

Event Description

It was reported that during a minimally invasive hip procedure a flexible reamer broke intra operatively on (b)(6) 2015.While reaming the reamer shaft snapped at the junction of the drill connector.A back-up shaft was available immediately for use.Fragments were generated but all were easily removed and none were left in the patient.The facility reported no surgical delay and did not report any additional intervention.The surgery was successfully completed.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device investigation summary ¿ the returned device was examined and the complaint condition of broken was able to be confirmed as the shaft had broken at the coupling joint generating at least six (6) fragments, five (5) of which were returned.A definitive root cause was unable to be determined; this failure mode is consistent with the application of excessive loads applied to the device.The flexible shaft (352.040) is used in operations when reaming is utilized and is noted in nine (9) technique guides.The returned device was examined and the complaint condition of broken was able to be confirmed as the shaft had broken at the coupling joint generating at least six (6) fragments, five (5) of which were returned.The fragments were able to be reassembled and it was found that a portion of the shaft was not returned, approximately 15mm x 5mm.The length of the reassembled shaft was checked against the drawing and found to be within specification.A definitive root cause was unable to be determined; this failure mode is consistent with the application of excessive loads applied to the device.This could be the result of using a non-synthes drill which applied too much torque, or skipping head sizes while reaming (not using 0.5mm increments).Device drawings were reviewed; the design, materials and finishing processes were found to be appropriate for the intended use of the device.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.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• 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: 5220754
• MDR Text Key: 31035859
• Report Number: 9612488-2015-10563
• Device Sequence Number: 1
• Product Code: HTO
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 2317417
• Other Device ID Number: (01)10886982194114(10)2317417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2008
• 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