MAUDE Adverse Event Report: SYNTHES TUTTLINGEN ROD HOLDING FORCEPS FOR 6.0MM RODS

Catalog Number	388.44
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Device manufacture date reported only as week 28, 2000.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The correct lot # is a7ja28.Manufacturing date: week 28 2000.A dhr review can not be performed as the dhr is no longer available due to the age of the device (over 16 years old).The exact manufacturing date is unknown.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.
Event or Problem Description
It is reported during an initial scoliosis correction procedure on (b)(6) 2017, one screw on the rod holding forceps was broken into two (2) pieces.The head of the broken screw fell onto the floor and was easily retrieved.The shaft of the broken screw remains in the rod holding forceps.In addition, a second screw on the device became loose during rod rotation, causing the spring of the rod holding forceps to come apart.Procedure was completed successfully utilizing another rod holding forceps with no delay and no harm to patient.This report is for one (1) rod holding forceps.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
(b)(6).A product investigation was completed: during the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test, and drawing review were performed as part of this investigation.A device history record (dhr) review was unable to be completed due to the product¿s age.This complaint is confirmed.Per the technique guide, the rod holding forceps are used to place the rod into polyaxial screws.The ratchet-locking mechanism ensures a consistent and stable grip on the 6.0 mm rod.Quick release permits one-handed application for easy maneuvering and rod placement.A visual inspection under 5x magnification, and drawing review were performed as part of this investigation.A dhr review was unable to be completed due to the product¿s age.No product design issues or discrepancies were observed.The rod holding forceps were returned with the leaf spring detached from the handles of the instrument.One screw broke at the head, with the shaft remaining in the device and the head missing, and the other screw became loose and was returned with the device.There was noticeable use around the mouth of the forceps, and there is slight rust on the handle-spring leaf interfaces.The overall condition of the device is worn, which would be expected with the product¿s seventeen-year lifetime.Replication of the complaint condition is not applicable as the device was returned in damaged condition.The relevant drawings 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.The complaint conditioned is confirmed, as the head of one screw was not returned and the other screw was detached from the device.The returned device is multiple use and needed during various procedures; therefore, the complaint condition was most likely caused by numerous reprocessing cycles in combination with very intense use over the product¿s lifetime.However, based upon the given information, a definitive root cause is indeterminable.It is not likely that the design of the instrument contributed to this complaint.No new, unique or different patient harms were identified as a result of this evaluation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: ROD HOLDING FORCEPS FOR 6.0MM RODS
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6494186
• Report Number: 9680938-2017-10065
• Device Sequence Number: 16508480
• Product Code: HTD
• UDI-Device Identifier: 10705034772950
• UDI-Public: (01)10705034772950(10)A7JA28
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 388.44
• Device Lot Number: A7JA28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/02/2017; 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 61