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

Catalog Number 356.823

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown part/plate/screw/unknown lot number.Device is an instrument and is not implanted/explanted.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.A device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 24.May.2006, no ncrs were generated during production.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.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 distal end of the impactor broke off and remained in the patient.No delay to surgery time.Patient is fine.This complaint involves one part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).Product investigation summary: the investigation of the complained impactor f/pfna blade has shown that the complete length of the threaded shaft is broken off.The broken piece was not returned.Because of the damage, the complaint relevant dimensions could not be checked against the print specifications.The manufacturing document shows that the production procedure was according to specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.The broken surface is homogenous, which indicates material conformity as well.The instrument was manufactured in may, 2006.It is clearly visible that this impactor had been used in many applications.The complete instrument is baldly worn and damaged.Because of the visible hammering marks at the front side of the handle (against the insertion direction), it is likely that the instrument was subjected to excessive use which most likely led to this complained issue.Based on these findings, the cause of failure could not be attributed to any manufacturing-related non-conformances.No indication for product related issues were found.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: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5434406
• MDR Text Key: 38146409
• Report Number: 9612488-2016-10086
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2184336
• Other Device ID Number: (01)07611819291317(10)2184336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75