MAUDE Adverse Event Report: SYNTHES TUTTLINGEN COMPRESSION/DISTRACTION INSTRUMENT; INSTRUMENT COMPRESSION

Catalog Number 03.111.021

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the device history records has been requested and is currently pending completion.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

It was reported that a foot distractor (compression/distraction instrument) is missing a screw, rending the device unable to tighten.The issue was discovered during sterile processing with no patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: one compression/distraction instrument (part 03.111.021 / lot t974968) was received.Upon visual inspection of the complaint device, it can be seen that the tooth wheel assembly is missing from the device, which resulted in the complaint condition.A root cause could not be determined, but it is most likely the wheel assembly was disassembled from the instrument for cleaning and got misplaced during sterile processing.The complaint condition is confirmed.The compression/distraction instrument is part of synthes orthopaedic foot instrument system, which utilized for reconstructive orthopaedic surgery.The instrument allows for compression/distraction of joints or bones.The relevant drawing was reviewed.The design history was found to not impact the complaint condition.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.Device history record review: manufacturing location: (b)(4)- manufacturing date: april 30, 2012.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The original event description states that the discovered issue resulted in the ¿rending of the device unable to tighten.¿ this statement should read: ¿rendering the device unable to tighten.¿ 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: COMPRESSION/DISTRACTION INSTRUMENT
• Type of Device: INSTRUMENT COMPRESSION
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5206128
• MDR Text Key: 30572569
• Report Number: 9680938-2015-10104
• Device Sequence Number: 1
• Product Code: HWN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.111.021
• Device Lot Number: T974968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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