MAUDE Adverse Event Report: SYNTHES SELZACH SHAFT F/AWL F/04.630.135S

Catalog Number 03.630.144

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

It is unknown if there was patient involvement.Date of event: unknown.Device is an instrument and is not implanted/explanted.On an unknown date the device was received.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: july 02, 2015.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that two instruments with broken tips received.The information surrounding the breakage of the instruments is unknown.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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

Update 18.July 16, material received on 15.July 16.Additional updated information received 25.July 16.The tips broke during surgery.The patient harm was (prolongation of surgery in minutes, reoperation, etc.) no impact on surgery and patient.No information on patient data (patient identifier, age or date of birth, gender, weight, comorbidities - smoker, obese etc.) fragment(s) were generated and the fragment(s) removed easily without additional intervention or difficult and required no additional intervention with no fragment left in the patient.Procedure was successfully completed.

Manufacturer Narrative

It was reported there was patient involvement; however, patient information is unknown a product investigation was completed: one awl was found broken.The broken part is missing.The second awl is partially distorted and bent at the flutes.Based on the investigation results and the received information we cannot determine the exact root cause.Due to the wear and tear signs on the devices, it is likely that these products were intensively used.The microscopic view of the broken surface shows a homogenous surface what indicates material conformity.Because of the damage on both devices, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.The article in question was produced in july 2015.It is likely that both awls have had interference with a metallic device during use and this impact has probably led to these damages as result.It was concluded that the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected.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: SHAFT F/AWL F/04.630.135S
• Type of Device: AWL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5802170
• MDR Text Key: 49797204
• Report Number: 3000270450-2016-10172
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.630.144
• Device Lot Number: 1502741
• Other Device ID Number: (01)07611819588028(10)1502741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 07/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/02/2016; 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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