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

Catalog Number 399.99

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 Description

It was reported that the tip of the clamp on bone reduction forceps broke off during a pelvis open reduction internal fixation (orif).It is unknown at what point in the procedure that this occurred.There was a reported 10-15 minute surgical delay.It is unknown if additional x-rays were required.The broken tip was retrieved.No fragments left in patient.The procedure was completed successfully and patient was reported as stable.(b)(4).

Manufacturer Narrative

Additional narrative: a service & repair evaluation/review was attempted; the report indicates that the: no service history review can be performed as part number 399.99 with lot number(s) a7da25 is a lot/batch controlled item.The service history review is unconfirmed.Device history records review was attempted.The report indicates that the: manufacturing date: week 7 in 1994.The dhr is no longer available in tuttlingen due to the age of the instrument (over 23 years old).Therefore the exact date of manufacture is unknown.Product was not returned, device was discarded by the hospital.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.Device used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.Product was not returned.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 TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6853285
• MDR Text Key: 86108840
• Report Number: 9680938-2017-10130
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982203175
• UDI-Public: (01)10886982203175(10)A7DA25
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• 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: A7DA25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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