MAUDE Adverse Event Report: SYNTHES BETTLACH LOCKING CALCANEAL PLATE CUTTER; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number 329.151

Device Problem Break (1069)

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

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Device history review showed; manufacturing location: (b)(4), manufacturing date: june 16, 2009.No non-conformance reports (ncrs) 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported during a calcaneus open reduction and internal fixation (orif) procedure on (b)(6) 2016, the locking calcaneal plate cutter broke.The device functioned correctly when cutting the first plate.However, when attempting to cut the 87mm calcaneal y-plate, the pin on the plate cutter that holds the plate in place bent and then fell out.Device was not being used near the sterile field; no fragments fell into the patient.A bolt cutter was used in place of the plate cutter.Procedure was completed successfully with approximately a 5 minute delay but no harm to patient.Concomitant medical products: 87mm calcaneal y-plate (part 241.65, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.A product development investigation was performed for the calcaneal plate cutter(part number 329.151, lot number 2496486).The subject device was returned with the complaint condition stating the plate holder block is broken off.The break occurred at the location where the plate holder block is secured to the handle with a pin.The balance of the returned device shows worn edges and signs of wear along the length of the device.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.A visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.Additionally, the calculated occurrence rate is acceptable with the applicable design and clinical risk management occurrence rate.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.No non-conformance records (ncrs)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.A review of the current design drawing was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The investigation was unable to determine a definitive root cause.However, the complaint condition was most likely caused by instrument wear due to excessive force or cumulative wear due to repeated usage.It is not likely that the design of the device contributed to this complaint.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKING CALCANEAL PLATE CUTTER
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6050245
• MDR Text Key: 58143863
• Report Number: 9612488-2016-10426
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.151
• Device Lot Number: 2496486
• Other Device ID Number: (01)10886982191854(10)2496486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2009
• 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
• Treatment: Y-PLATE (PART 241.65, LOT UNKNOWN, QUANTITY 1)
• Patient Age: 37 YR