MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM

Catalog Number 03.019.020

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/02/2023

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.H10 additional narrative: e3: reporter is a synthes employee.H3, h6: part: 03.019.020.Lot: 8318590.Manufacturing site: werk hagendorf.Supplier: na.Release to warehouse date: 12 april 2013.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that scrdriver t25 w/coupl f/03.019.019 l330 was found worn from the distal tip.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.The device exhibits damage consistent with repeated use.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed worn of scrdriver t25 w/coupl f/03.019.019 l330 would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.Drawing/specifications reviewed.Screwdriver stardrive t25 (current and manufactured.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

Device report from (b)(6) reports an event as follows: it was reported that patient underwent open reduction internal fixation (orif) on (b)(6), 2023, for fracture of proximal humerus with stardrive screwdriver and multiloc humeral nail and endcap.The surgery proceeded smoothly, but it became difficult to insert the end cap at the stage of inserting it.The nail was slightly over-inserted, so the surgeon opted for a 2mm endcap, which could not be inserted.The surgeon verified the orientation of the driver from various angles, and attempted to refasten it, but was unable to insert it.The surgeon was concerned that the endcap would come off, so tried to remove it.However, the end cap was stuck between the head subchondral bone and the nail and could not be pulled out.Eventually, the surgeon managed to extract it.The surgeon again tried to place the endcap again.Again, it became difficult to insert, but after several attempts, the surgeon was finally able to insert the end cap firmly.The surgeon believes that there was a possibility that something was interposed between the end cap and the nail, or that the center of the entry hole and the nail, which should have been coaxial, was slightly misaligned when the handle was removed.The surgeon also expressed dissatisfaction with the screwdriver and suggested that if it had an attachment mechanism for the end cap, even if insertion was difficult, extraction would not have been difficult.The surgery was completed successfully with over forty minutes delay.Patient was stable.Upon manufacturer investigation, it was determined that the screwdriver was found worn from the distal tip.This report is for a stardrive screwdriver t25 w/ coupling for 03.019.019/330mm.This is report 3 of 3 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17825045
• MDR Text Key: 324359809
• Report Number: 8030965-2023-12208
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819427204
• UDI-Public: (01)07611819427204
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.020
• Device Lot Number: 8318590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2013
• 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: UNK - END CAPS; UNK - NAILS: MULTILOC HUMERAL