MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/ PFNA BLADE

Catalog Number 03.010.410

Device Problems Break (1069); Material Fragmentation (1261); Device Operates Differently Than Expected (2913)

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

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This report is for unknown impactor f/pfna blade 03.010.410/unknown lot number.Device is not distributed in the united states, but is similar to device marketed in the usa device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Subject device has not been received.Without a lot number, the device history record review and 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

Device report from synthes on an event in (b)(6) as follows: it was reported that during operation the handle was broken.No surgical delay.During impacting the blade the handle started to crack on the middle part of the handle.It happened during surgery but did not effect the result of the operation.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 09 september 2015.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute 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.

Manufacturer Narrative

The device is not distributed in the united states, but a similar device is marketed in the us.Product investigation summary: during investigation of the received instrument, it was observed that the instrument is broken at the blue handle, as mentioned in the complaint description.Also, the blue handle exhibited some damage on the proximal side as well (hard stricken and/or strapped with another instrument).Furthermore, on the head at the distal end, there are strong impact marks visible.Welding was also seen between the handle and the shaft.Based on the provided information, it is impossible to determine the exact cause for this occurrence.It is likely that either wear and tear from frequent use with excessive force through hammer-blows led to this damage.Based on these findings, the cause of failure is not due to any manufacturing non-conformances.The additional product code (hwe) reported in the initial medwatch was reported in error.Only hwa ¿ impactor is applicable for this device.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: it was further reported that all of the generated fragments were retrieved.

• Brand Name: IMPACTOR F/ PFNA BLADE
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5773008
• MDR Text Key: 48923080
• Report Number: 2520274-2016-13371
• Device Sequence Number: 1
• Product Code: HWA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2016

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: 03.010.410
• Device Lot Number: 9596712
• Other Device ID Number: (01)07611819349476(10)9596712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/12/2016; 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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