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

Catalog Number 329.151

Device Problem Component Missing (2306)

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

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4).Manufacturing date: may 10, 2010.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Device 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

Device report from synthes (b)(4) reports an event as follows: it was reported that a patient underwent an open reduction internal fixation (orif) calcaneus procedure on (b)(6) 2016.It was noted that the pin/screw from a calcaneal plate cutter was missing.The instrument is routinely used to hold a calcaneal plate as the tabs are being cut for insertion.The surgeon reportedly used the same cutter to complete the procedure without delay or patient harm.Concomitant devices reported: calcaneal plate (part/lot/quantity: unknown).This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Additional narrative: an investigation summary was performed.The investigation of the complaint articles has shown that: the cutters were received with the complaint that device is missing the seating pin.This condition is confirmed; the distal seating pin which locks into the plate was not attached to the returned device and not returned with the complaint.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 component is already missing.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.During the 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 product design issues or discrepancies were observed.This complaint is confirmed.Device 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.

Manufacturer Narrative

Device 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: 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: 5885677
• MDR Text Key: 52410151
• Report Number: 9612488-2016-10340
• 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,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• 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: 2599955
• Other Device ID Number: (01)10886982191854(10)2599955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2010
• 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