MAUDE Adverse Event Report: SYNTHES GMBH 4.0MM THREADED DRILL SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	395.922
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent external fixation for a distal radius fracture with the products in question.With the rods and clamps of a z frame external fixator, the surgeon attempted to drill a 2.5/4.0 seldrill using a 4.0 mm threaded drill sleeve, but the seldrill jammed in the sleeve and could not be inserted into the bone.He checked if he had inserted the seldrill at an angle, but it still did not pass.He tried to puncture with other seldrills, but all of them experienced interference in the sleeve.The surgeon was able to complete this step using another product, and the procedure was completed successfully with a delay of under 30 minutes.After cleaning the drill sleeve, it is found that the inside of the sleeve there was a burr-like object had formed around the circumference of the sleeve, causing the 4.0 cell drill to poke into it.No further information is available.This report is for a 4.0mm threaded drill sleeve.This is report 1 of 5 for (b)(4).
Additional 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part number: 395.922, lot number: 26p0970, manufacturing site: haegendorf, release to warehouse date: 27 december 2019.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 the drillsl 4 was found damage on the id that is causing the pins not going through.The root cause of the issue it is unknown.The ends of device were checked and the proper size of pin gage go in up to the damaged area.A dimensional inspection was performed for the drillsl 4 and met specifications.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A functional test was performed with different sizes of pin gage.Only the pin gage of 3.95 mm pass through.The pin gages of 4.05 mm, 3.99 mm and 3.97 mm did not pass through.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 condition of the drillsl 4 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: 4.0MM THREADED DRILL SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15639323
• Report Number: 8030965-2022-08480
• Device Sequence Number: 6387242
• Product Code: LXH
• UDI-Device Identifier: 10886982200938
• UDI-Public: (01)10886982200938
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Model Number: 395.922
• Device Catalogue Number: 395.922
• Device Lot Number: 26P0970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 12/15/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/07/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SELDRILL-SCHANZSCR Ø4/2.5 L80/20 TI; SELDRILL-SCHANZSCR Ø4/2.5 L80/20 TI; SELDRILL-SCHANZSCR Ø4/3 L100/20 TI; SELDRILL-SCHANZSCR Ø4/3 L100/20 TI
• Patient Sex: Unknown