MAUDE Adverse Event Report: SYNTHES BETTLACH LARGE HANDLE WITH QUICK COUPLING; TAP, BONE

Catalog Number 311.431

Device Problem Break (1069)

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

Event Date 10/17/2014

Event Type  malfunction  

Event Description

It was reported that during a hardware removal surgery, for an unknown reason, on (b)(6) 2014, the holding pin came out of the large handle with quick coupling that resulted in the handle coming apart during surgery.There was an additional instrument available and the procedure was completed.There was a 4 to 5 minute surgical delay and no patient harm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.No nonconformance reports 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.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a product development evaluation was completed: one part 311.431 was received intact.The set screw on the coupling is removed and was returned.The device is in good condition with minimal marks from routine use.The returned device shows light use during its 12 month lifespan.The handle and coupling of the device is in good condition with minimal scratches and marks from routine use.The retention pin from the coupling is out, and was returned.The drawing for the device(s) was reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The complaint condition was most likely caused by method of use, disassembly during sterilization, rather than the design of the instrument.Though the exact cause cannot be determined, this complaint condition is likely a result of method of use or inattentiveness during sterilization; and not the device's design.Because of this, the complaint is determined not to be a result of a detected design deficiency.The returned part(s) are determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, but the design of the device did not contribute to this complaint.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: LARGE HANDLE WITH QUICK COUPLING
• Type of Device: TAP, BONE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4245694
• MDR Text Key: 4986769
• Report Number: 9612488-2014-10506
• Device Sequence Number: 1
• Product Code: HWX
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.431
• Device Lot Number: 8537029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• 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