MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCR FOR TI FEM & TIB NAIL; EXTRACTOR

Catalog Number 357.133

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found the threaded tip stripped.The observed condition was consistent as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was unconfirmed as there is no allegation associated with the [extraction scr for ti fem & tib nail] associated to this complaint.However damage could be observed and would contribute to a device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The following drawings reflecting the current and manufactured revisions were reviewed: dwg se_580137 rev d.Manufactured, dwg se_580137 rev e current.H4, h6 part number: 357.133 lot number: 295p548 manufacturing site: (b)(4).Release to warehouse date: 30th july 2021 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 surgeon removed a tibial nail on (b)(6) 2023 because of a possible infection.The nail was difficult to remove for various reason.Surgeon was unable to connect the appropriate extractor for the ex locking nails and therefore had to try multiple options and eventually a competitor's conical extractor successfully extracted the nail.There were already previous unknown fragments as well from when the surgeon was attempting to remove a difficult interlocking screw.The most distal screw was buried in bone and eventually was knocked out successfully.Additionally, one of the wrappers of a 3.0 reaming rod split.Sales rep offered to grab a new reaming rod, however the surgical tech and nurse decided to use that one.Sales rep did not confirm if fragments were removed from the tibia after the removal.Surgery was completed successfully with a delay of forty five (45) minutes.After the surgery, it was noticed in sterile processing department (spd) that the extraction screw threads have been damaged.This report captures the postop event of infection, while the intra op event of extraction screw thread damage and one of the wrappers of a 3.0 reaming rod breakage are captured under related complaint (b)(4).This report is for one (1) extraction scr for ti fem & tib nail.This is report 3 of 5 for complaint pc-(b)(4).

• Brand Name: EXTRACTION SCR FOR TI FEM & TIB NAIL
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): HAEGENDORF; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18002709
• MDR Text Key: 326470608
• Report Number: 8030965-2023-13420
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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: 295P548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2021
• 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: 10 TI CANNULATED TIBIAL NAIL-EX/375-SILE; 3.0 REAMING ROD/950 STR BALL TIP - SILE; SHUKULA SET; STRYKER CONICAL EXTRACTOR; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Age: 32 YR
• Patient Weight: 94 KG