MAUDE Adverse Event Report: SYNTHES USA REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

Catalog Number 399.99

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

It was reported that the reduction forceps with serrated jaw-ratchet 144mm were loose, and when the surgeon clamped them down, the forceps would not stay clamped.The surgeon was able to use a spare device to complete the procedure with no negative impact or any time delay.There are 2 parts in this complaint.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Without a valid lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Service history review: lot #204.30, no service history review can be performed because the lot number cannot be traced.The manufacture date is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Report was initially submitted on february 19, 2015, but the fda site was down.Advised by fda on february 27, 2015 to resubmit medwatch.Service and repair evaluation: the customer reported the item was loose.The repair technician reported the item was bent.The item is not repairable.The cause of the issue is unknown.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

A product investigation was completed: the returned devices shows regular use during their minimum 16 year lifespans.The handles have minor scratches and marks consistent with regular use.The tip of the serrated jaws on both devices is worn.The ratcheting mechanism on both devices is slightly loose, but the holding mechanism functions as intended.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.Although the exact cause cannot be determined, the complaint condition is most likely the result of torsional forces places on the device during use.This complaint is unconfirmed.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.Per the technique guide, the forceps are used to reduce and secure axial alignment of fragments prior to fixation for the 2.7 and 3.5mm plating systems.The complaint condition was most likely caused by excessive reduction force, rather than the design of the instrument.There were no issues found with the returned device.The design is adequate for its intended use, it did not contribute to the complaint condition, and it is consistent with the calculated risk assessment occurrence rate.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

Device was reported as returned when evaluation was reported on previous follow up.On may 14, 2015 the date device was received by manufacturer was determined.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

Service history review: lot #9234 no service history review can be performed because the lot number cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.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: REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3925434
• MDR Text Key: 4667965
• Report Number: 2520274-2014-12484
• Device Sequence Number: 1
• Product Code: HTD
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.99
• Device Lot Number: 9234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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