MAUDE Adverse Event Report: SYNTHES BRANDYWINE TIP FOR DHS®/DCS® IMPACTOR (338.28)

Catalog Number 338.26

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.There was no known reported patient involvement associated with the complained event.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.A device history record review was performed for the subject device lot number, 4152301.Manufacturer: (b)(4).Date of manufacture: nov 24, 2000.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.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

It was reported that the tip for impactor was found in the sterile processing department with a split and a piece broken off.It is unknown when this damage occurred.There is no known patient or surgical involvement associated with the reported condition.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 338.26 with lot number(s) 4152301 is a lot/batch controlled item.The manufacture date of this item is november 24, 2000.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.A service and repair evaluation was completed: the customer reported the tip of the impactor was found split with a piece broken off.The repair technician reported the tip broke off.Tip broken is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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

An investigation summary was performed.The investigation of the complaint articles has shown that: it was reported that the tip of the impactor was found split and a piece broken off.This was found by the reporter in the sterile processing department.There is no known patient involvement or surgical procedure at this time.This complaint involves one device.The returned instrument was examined upon receipt at customer quality (cq) and the complaint condition was able to be confirmed as the plastic tip was found to be broken off and not returned.The balance of the device appears to be in fair condition with minimal signs of wear.Whether this complaint can be replicated is not applicable as the device is already broken.No definitive root cause was able to be determined however the failure mode is consistent with rough handling during impaction for this nearly 16 year old reusable instrument.A visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.Additionally, the calculated occurrence rate is acceptable with the applicable design and clinical risk management occurrence rate.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: TIP FOR DHS®/DCS® IMPACTOR (338.28)
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5907039
• MDR Text Key: 53121765
• Report Number: 2530088-2016-10230
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.26
• Device Lot Number: 4152301
• Other Device ID Number: (01)10886982193292(10)4152301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2000
• 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