MAUDE Adverse Event Report: SYNTHES TUTTLINGEN SLOTTED MALLET; HAMMER,SURGICAL

Catalog Number PDL102

Device Problems Break (1069); Component Falling (1105)

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted / explanted.Device history records review was completed for part # pdl102, lot # a7oa46.Manufacturing date: feb 06, 2006.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% at the final inspection on nov 11, 2005.No non conformance reports were generated during production.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

It is reported that on (b)(6) 2016, patient underwent an initial transforaminal posterior atraumatic lumbar (tpal) procedure at l4 to l5.During the procedure, as surgeon was using the slotted mallet to hammer down on the tpal spacer applicator handle, the plastic piece on the end of the mallet fell off.No pieces or fragments fell into the patient.Surgeon completed the procedure successfully utilizing the complained device with no delay and no harm to patient.Concomitant devices reported: tpal spacer applicator handle (part 03.812.001, lot unknown, quantity 1).This report is for one (1) slotted mallet.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device (slotted mallet), part number pdl102, lot number a7oa46.The subject device was returned with the complaint condition stating during an initial transforaminal posterior atraumatic lumbar (tpal) procedure at l4 to l5, as surgeon was using the slotted mallet to hammer down on the (tpal) spacer applicator handle, the plastic piece on the end of the mallet fell off.No pieces or fragments fell into the patient.Surgeon completed the procedure successfully utilizing the complained device with no delay and no harm to patient¿.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.The slotted mallet is a component of the prodisc-l instrument set.The prodisc-l system is ¿intended to replace a diseased and/or degenerated intervertebral disc of the lumbosacral region¿, between l3 and s1).The slotted mallet is used throughout prodisc-l procedures: inserting trials, chiseling and inserting the implant endplates.Upon visual inspection of the device it can be seen that the portion of the plastic cap has sheared off from the device.The complaint condition is confirmed.Drawings for the slotted mallet were reviewed, specifically the top level drawing.The drawing was found suitable to determine the intended device design, application and dimensional conformity.The mallet was found to have met the drawing specifications.A device history review was performed for all returned instruments lot number and no mrrs, ncrs or complaint-related issues were identified with the lots number which may have contributed to the complaint condition.No definitive root cause was able to be determined however the failure mode is consistent with the repeated use of excess force for impaction.The calculated occurrence rate is acceptable under the system risk assessment.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: SLOTTED MALLET
• Type of Device: HAMMER,SURGICAL
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6064058
• MDR Text Key: 58715187
• Report Number: 9680938-2016-10164
• Device Sequence Number: 1
• Product Code: FZY
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PDL102
• Device Lot Number: A7OA46
• Other Device ID Number: (01)10705034700205(10)A7OA46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2006
• 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
• Treatment: PART 03.812.001, LOT UNKNOWN, QUANTITY 1
• Patient Age: 47 YR
• Patient Weight: 145