MAUDE Adverse Event Report: SYNTHES TUTTLINGEN AWL 12MM

Catalog Number 03.820.100

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Manufacturing date: september 18, 2007.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 parts of the lot were checked 100% for features and for function at the final inspection.No non-conformance reports were generated during production.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 was found broken off of the awl during inspection activities of the evaluation set.There was no patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.One (1) 12mm awl (part 03.820.100, lot a7qa38, mfg 18-sep-2007) was returned with a complaint stating that the tip of the awl was discovered broken during inspection of the evaluation set.The complaint was able to be confirmed at customer quality as a portion of the distal tip had sheared off.A visual inspection and drawing review were performed as part of this investigation.Replication of the complaint is not applicable as the device was received broken.The broken fragment was not returned.Although the definitive root cause could not be determined, the pattern of the deformation insists that the damage likely occurred during a clockwise twisting motion during use.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The 12mm awl (also referred to as the center punch) is an instrument regularly used in the prodisc-c modular intervertebral disc prosthesis systems (per relevant technique guide).The awl is used to perforate the anterior cortex of the superior and inferior vertebra in the lateral midline and vertical center.Product drawing was reviewed during the investigation.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AWL 12MM
• Type of Device: AWL
• 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: 5986593
• MDR Text Key: 56546543
• Report Number: 9680938-2016-10153
• Device Sequence Number: 1
• Product Code: HWJ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.820.100
• Device Lot Number: A7QA38
• Other Device ID Number: (01)10705034731360(10)A7QA38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2007
• 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