MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE PERF L100 SST; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 02.027.035S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: additional device product code is hwc.(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot number 9804670.Manufacturing location: synthes (b)(4).Date of manufacture: feb 2, 2016.Expiration date: jan 1, 2026.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2016, the proximal femoral nail antirotation (pfna) blade could not be inserted.The surgeon reportedly has had prior experience with the pfna system.The blade was exchanged and the surgery could be finalized successfully, but with a prolongation of 20 minutes.Concomitant devices reported: pfna nail (part: unknown, lot: unknown, quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Other number¿udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

Manufacturer Narrative

A product development investigation was performed for the subject device (pfna blade perf l100 sst), part number 02.027.035s, lot number 9804670.The subject device was returned with the complaint condition stating the received proximal femoral nail antirotation (pfna) blade shows small damages and scratches at the surface and on top of the implant.The blade was tested with an impactor instrument and it was detected, that the (pfna) blade could be locked and unlocked without any problems.A functional test was performed and has shown that the blade is fully functional.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Due to the fact, that the item is fully functional the exact cause which has led to this complaint was not able to determined.The complaint could not be replicated with the returned 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.

• Brand Name: PFNA BLADE PERF L100 SST
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6127712
• MDR Text Key: 60878809
• Report Number: 9612488-2016-10480
• Device Sequence Number: 1
• Product Code: HSB
• 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,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.027.035S
• Device Lot Number: 9804670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN PFNA NAIL