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

Model Number 357.133

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that, after inspection of the back up instruments, these were set aside for complaints.No patient involvement.This report is for one (1) extraction screw for ti femoral and tibial nails.This is report 5 of 7 for complaint (b)(4).

Manufacturer Narrative

Reporter is a synthes employee.Part: 357.133 lot: 3030229 manufacturing site: (b)(4).Release to warehouse date: january 21, 2009.The device history record shows this lot of was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Visual inspection: the complaint device extraction scr for ti fem & tib nail (product code: 357.133, lot number: 3030229) was returned to customer quality (cq) west chester for investigation.The extraction screw tip severely damaged with threads peeling off the device.The device had deformed and started to corrode.According to procedure, these issues are identified as end of life indicators for the device.Device/defect identified: yes document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dimensional inspection: this was not performed as the defects identified are consistent with failure associated with use of the device.Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the item had been worn due to usage and according to procedure no further investigation is needed on the device as this is end life for the extraction screw.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13061129
• MDR Text Key: 288210788
• Report Number: 2939274-2021-07195
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 357.133
• Device Catalogue Number: 357.133
• Device Lot Number: 3030229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2009
• 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: 3.5 VA LCKNG SCR SLF-TPNG/SD/85; BENDING IRON FOR 2.7MM & 3.5MM PLATES; CANN CONNECTING SCREW FOR STD INSRT H≤ CANNULATED 2.5MM HEXAGONAL SCREWDRIVER; DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS; DEPTH GAUGE FOR LCKNG SCRS TO 100; DEPTH GAUGE FOR LCKNG SCRS TO 100; GD BLK 2.7/3.5 VA ANTLAT DSTL TIB PL/RT; SCRDRIVERSHAFT-HEX-LRG Ø3.5 L165 F/QC; SCREWDRIVER, HEXAGONAL, SMALL, WITH HOLDING SLEEVE; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SHARP HOOK; SMALL HEXAGONAL SCREWDRIVER SHAFT; UNK - SCREWDRIVERS