MAUDE Adverse Event Report: SYNTHES BETTLACH BENDING TEMPLATE 22 HOLES F/3.5MM CURVED RECON PLATES

Catalog Number 329.660

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

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

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).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.Without a lot number the device history records review could not be completed.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

Report from synthes (b)(4) reported an event in the (b)(6) as follows: it was reported that the bending template broke three times during a surgery to repair a pelvic fracture on (b)(6) 2016.The first break occurred where the surgeon gently bent it.Subsequently broke at two other places the surgeon bent it.No fragments were reported to have fallen into the patient's wound.The surgeon successfully completed the surgery without using the reported template.There was no reported surgical delay or patient harm.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Additional narrative: updated lot information.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 history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: (b)(4) 2015, 329.660 / lot no: 9469043.Review of the device history record (s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Synthes manufacturing location was discovered upon receipt of subject device.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.

Manufacturer Narrative

Additional narrative: hospital contact number: (b)(6).Product investigation summary: the received instrument is broken as mentioned in the complaint description and shows a lot of signs of use.A device history record (dhr) review was performed for the affected lot with no abnormalities or deviations detected.The article was manufactured in may, 2015.No non-conformance reports were marked in the dhr during production.Based on these findings, the likely cause of failure was not due to any manufacturing non-conformances.Please note, multiple bending cycles forwards- and backwards may have led to the breakage of the material.The product in question showed a lot of signs of use; therefore, this complaint was classified as being the result of normal wear and tear.No product fault could be detected.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.

• Brand Name: BENDING TEMPLATE 22 HOLES F/3.5MM CURVED RECON PLATES
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5521141
• MDR Text Key: 41028036
• Report Number: 2520274-2016-11807
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 07611819021433
• UDI-Public: (01)07611819021433(10)9469043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2016

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: 329.660
• Device Lot Number: 9469043
• Other Device ID Number: (01)07611819021433(10)9469043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: 04/27/2016; 04/27/2016
• Supplement Dates FDA Received: 04/15/2016; 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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