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

Catalog Number 03.111.021

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Date of event: exact date of event is unknown.Implant and explant dates: device is an instrument and is not implanted or explanted.The complainant part has not been received for review/investigation.Initial reporter: hospital contact number: (b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing date: december 20, 2011.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 raw material, which was delivered as lots 330133 and 301270, are corresponding to the specifications.For both lots, the hardness was measured at the time of the manufacturing and found to be 48.5 hrc, which was good.No non-conformance reports were generated during production.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 in the (b)(6) as follows: it was reported that swivel of the compression instrument fell out during surgery due to a missing screw.A loanset device was used to complete the procedure.A five (5) minute surgical delay was noted.Per the reporter, the device is disassembled frequently by the sterilization department, which may have resulted in the loosening part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional 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: a product investigation was completed: the investigation has shown that the tooth wheel tip of the thumb screw is missing as complained.The review of the production history revealed that this instrument was manufactured in december 2011 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.In addition, the assembly process requests that each tooth wheel tip is secured to the thumb screw with an adhesive and that they are visually and function checked 100% before they leave the manufacturing facility.Unfortunately, the exact cause of failure could not be determined.The dimension cannot be checked due to missing component part.Although the exact cause cannot be determined, this complaint condition is likely a result of wear from normal use/cleaning, the complaint is determined not to be a result of a detected manufacturer or design deficiency.There was no indication for material or design related issue.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: 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: 5060564
• MDR Text Key: 25193518
• Report Number: 9680938-2015-10085
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• 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: T968412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1