MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

Catalog Number	398.41.96
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation; the results are pending completion.A device history record review was attempted for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: week 27, 2001.The device history records are no longer available due to the age of this instrument (over 15 years old).The exact date of manufacture is unknown.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 was reported that while performing a suprapatellar tibial nailing procedure the surgeon had inserted the tibial nail and while attempting to drill for the proximal interlocking screws, the drill bit hit the nail.The surgeon was concerned there was an alignment issue with the synthes aiming devices.The surgeon then attempted to drill for another interlocking screw and was successful.Upon addressing the previous screw, she attempted to drill again and was successful in drilling and placing the screw.The patient also had a distal fibula fracture.While trying to place a bone clamp around the fracture, one tip of the reduction forceps broke off.The fragment was retrieved and discarded.There was a two (2) minute delay due to the reported event.The surgery was completed successfully with another clamp.The patient postsurgical outcome was reportedly fine.Concomitant devices reported: tibial nail (part #unknown, lot # unknown, quantity 1), drill bit (part #unknown lot #unknown, quantity 1).This report is 4 of 4 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: a visual inspection, device history record review, and drawing review were performed as part of this investigation.This complaint is confirmed.Per the technique guide, the 398.41.96 reduction forceps are an instrument routinely used in the variable angle locking hand system.The device was returned and reported to have broken during surgery.This condition is confirmed; one of the distal jaws has sheared off along the surface nearest the hinge of the device.It is likely that over fifteen years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in 2001 and is over fifteen years old.The balance of the returned device is in otherwise functional condition with some superficial wear.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no non-conformance reports germane to the complaint condition were generated during the production of this device.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: REDUCTION FORCEPS WITH POINTS BROAD-RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6372228
• Report Number: 9680938-2017-10030
• Device Sequence Number: 11014955
• Product Code: HTD
• UDI-Device Identifier: 10886982201393
• UDI-Public: (01)10886982201393(10)A7KA27
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2017

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: 398.41.96
• Device Lot Number: A7KA27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DRILL BIT, QUANTITY 1; UNKNOWN TIBIAL NAIL, QUANTITY 1
• Patient Age: 62 YR
• Patient Weight: 80