MAUDE Adverse Event Report: SYNTHES SELZACH JOINT PREP/CHISEL/STRAIGHT NARROW/10MM WIDE; CHISEL, SURGICAL INSTRUMENT

Catalog Number 03.111.015

Device Problem Mechanical Jam (2983)

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

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery the chisel could not be removed from the handle resulting in a 20 minute surgical delay.There was no harm to the patient.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A manufacturing evaluation was completed: the device was received with dents at the coupling end.Supplier (b)(4) manufactured the device.The parts were made to specifications.No manufacturing related issues were found.The chisel is made from hardened and tempered stainless steel; function and hardness parameters were checked randomly at the time of manufacturing and did comply with the specifications.The dimensions of coupling part checked and found to be according to the specifications.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: JOINT PREP/CHISEL/STRAIGHT NARROW/10MM WIDE
• Type of Device: CHISEL, SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5142393
• MDR Text Key: 28404391
• Report Number: 3000270450-2015-10198
• Device Sequence Number: 1
• Product Code: FZO
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.111.015
• Device Lot Number: 1403186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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