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

Catalog Number 338.26

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

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

Event Date 10/09/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device part# 338.26, lot# 3963165: release to warehouse date: 12-oct-1999, supplier: (b)(4).No non-conformances were generated during the 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.A product development investigation was performed for the subject device (tip for dhs®/dcs® impactor (338.28), part# 338.26, lot# 3963165).The wrench and the centering sleeve were not found to be connected when the devices were returned.The allegation that the wrench and centering sleeve would not come apart could not be confirmed.The returned dhs®/dcs® wrench (part# 338.06 lot# 3104848) was found to be scratched at the distal tip.The tip also shows multiple points of deformation.The remainder of the device is in good condition.The returned dhs®/dcs® centering sleeve long (part# 338.19, lot# 3063808) is fractured and badly malformed at the distal tip.There are metal shavings inside the device.The outside of the device is scratched and worn.The returned tip for dhs®/dcs® impactor (part: #388.26, synthes lot #3963165) is broken with fragments missing.In addition, the handle for the impactor (338.28.1) was returned.This part along with the tip for dhs®/dcs® impactor (part: #388.26) make up the impactor assembly (part# 228.28).The handle was able to attach to the tip appropriately.The handle shows signs of wear consistent with continued use.There is no allegation against the handle.There is no part or lot number etched on the handle meaning it was manufactured prior to revision.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.A visual inspection, complaint history review, drawing review, dhr review and risk assessment review were performed as part of this investigation.The complaint is confirmed.These parts are noted in two technique guides: lcp dynamic helical hip system (dhhs) technique guide and dhs/dcs dynamic hip and condylar screw technique guide.In both instances the impactor is utilized to aid in plate implantation and to ensure the plate is fully seated into position.The drawings were reviewed as part of investigation.The inner diameter of the proximal end of the centering sleeve was measured to be 10.98mm which is within specification of 11 mm +/- 0.04.No definitive root cause was able to be determined.It is likely that wear and deformation over years of consistent use and possible rough handling during surgery or sterile processing has led to this 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.

Event Description

It was reported that a patient underwent a procedure for a hip fracture (right side).There are three devices from a dynamic hip and condylar screw system (dhs/dcs) that were found to be damaged after a case on (b)(6) 2016.This was noticed on the back table when the patient was not in the room.The dhs®/dcs® wrench and centering sleeve long would not come apart.The impactor was cracked and would not come apart.There were shearings¿ and metal shavings around the devices.During the manufacturer investigation process it was identified that the returned tip for dhs®/dcs® impactor (part: #388.26, synthes lot #3963165) is broken with fragments missing.This condition was re-evaluated and was determined to be reportable on (b)(6) 2016.Concomitant device reported: handle of the dhs®/dcs® impactor (part# 338.28.1, lot# - unknown, quantity# 1).This is report 2 of 2 for (b)(4).

• 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: 6154484
• MDR Text Key: 61785683
• Report Number: 2530088-2016-10339
• 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
• Report Date: 10/09/2016

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: 338.26
• Device Lot Number: 3963165
• Other Device ID Number: (01)10886982193490(10)3963165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/1999
• 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
• Treatment: ONE (1) HANDLE OF THE IMPACTOR (PART # 338.28.1)