MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 357.133

Device Problem Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

It is unknown when the event occurred.Device is an instrument and is not implanted/explanted.Complainant part has been received, however, product investigation is not yet completed; no conclusion could be drawn.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 the end threads of the extraction screw are stripped.Sales consultant noted that the threads were flattened and damaged while inspecting field equipment.There was no patient involvement.This complaint involves one (1) device.(b)(4).This report is for an extraction screw.

Manufacturer Narrative

Reporters address.(b)(6).A device history record (dhr) review was performed for part no.: 357.133, lot no.: 1700244: manufacturing location: (b)(4), release to warehouse date: 25.Jun.2007: no non-conformance reports (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.A product investigation was performed.The returned extraction screw (part 357.133, lot 1700244, mfg 25.Jun.2007) was inspected at customer quality and the complaint was confirmed.Whether this complaint could be replicated is not applicable because the device was returned damaged.Dimensional analysis was not performed as relevant features are significantly deformed.Upon visual inspection, it was noted that distal threads are rolled over and deformed.There are slight impaction marks on the proximal end.Relevant drawings were reviewed and no design issues were identified.Material and relevant testing occurred at the time of manufacture and confirmed to have no issues through the dhr review.While no definitive root cause could be determined it is possible that the device encountered unintended forces (being threaded off axis or residual wear over the devices 10+ year life span).During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition, based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7222956
• MDR Text Key: 98522676
• Report Number: 8030965-2018-50632
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883(10)1700244
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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: 357.133
• Device Lot Number: 1700244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 03/02/2018
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2007
• 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