MAUDE Adverse Event Report: SYNTHES TUTTLINGEN PERIOSTEAL ELEVATOR 20MM STRAIGHT BLADE-ROUND EDGE

Catalog Number 399.38

Device Problem Break (1069)

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

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).A device history record review was attempted for the subject device lot 4615664, supplier lot number a7ma21.The subject device lot was manufactured on week 21, 2003 (exact date is unknown).The device history records for this instrument lot are no longer available since the age of the device is greater than 13 years.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) reported the following event: it was reported that the handle of the periosteal elevator broke into two pieces during an unspecified initial surgical procedure on (b)(6) 2016.There was no reported surgical delay or patient harm.This report is 1 of 1 for com- (b)(4).

Manufacturer Narrative

A product investigation was completed: the complaint condition is confirmed.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment, where applicable, was found to adequately address the complaint condition.Per the technique guide, the returned instrument is a common instrument used for pelvic implants and instruments.It is designed to simplify the dissection and atraumatic exposure of the bone.It serves to free the bone source from soft tissues in order to prepare the fractures surfaces for definitive fixation.The returned instrument was examined and the complaint condition was able to be confirmed as the device handle was found to have fractured along the cross-pin hole.The balance of the device shows surface wear and is in functional condition.A review of the current design drawing and available history for the instrument was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The device history record could not be done for the instrument because is no longer available due to the age of the instrument (over 13 years old).No definitive root cause was able to be determined however the failure mode is consistent with wear/tear of the instruments¿ phenolic handles which are susceptible to becoming brittle after being subjected to years of thermal cycling which routinely occurs during sterilization cycles.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: PERIOSTEAL ELEVATOR 20MM STRAIGHT BLADE-ROUND EDGE
• Type of Device: ELEVATOR
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5769195
• MDR Text Key: 48752596
• Report Number: 9680938-2016-10095
• Device Sequence Number: 1
• Product Code: HTE
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.38
• Device Lot Number: 4615664
• Other Device ID Number: (01)10886982202772(10)4615664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• 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