MAUDE Adverse Event Report: SYNTHES GMBH DRILLSL 4; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	395.922
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan 4as follows: it was reported that on (b)(6) 2023, the patient underwent the external fixation surgery for distal part of upper wrist with the products in question.This is a report of an event in which a cell drill f4-125mm became stuck in the sleeve and could not advance.In this surgery, two other f2.5/4.0 and one f3.0/4.0 were used, but they could be used without interference in the sleeve.Because the product in question was one of the last, the surgeon inserted the cell drill without using a sleeve.Sales confirmed that the cell drill was interfering with the sleeve by looking at the actual products.The surgeon commented that the sleeve itself is made tight, so it might be better to use it more carefully to avoid slanting when using the narrower sizes.The same event occurred six months ago.No further information is available.Concomitant device reported: seldrill-schanzscr ø4/2.5 l80/20 ti (part# 494.769s; lot# 619p075; quantity: 1), seldrill-schanzscr ø4/2.5 l80/20 ti (part# 494.769s; lot# 660p588; quantity: 1), seldrill-schanzscr ø4/3 l100/20 ti (part# 494.772s; lot# 9l63185; quantity: 1).This report is for one (1) drillsl 4 this is report 1 of 2 for complaint (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.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.
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.Investigation summary: 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 drillsl 4 had no signs of damage.A dimensional inspection was performed for the drillsl 4 and met specifications.A functional test was unable to be performed due to the mating device not being returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the drillsl 4 would not 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.Drawing/specifications reviewed: yes.Dimensional inspection: drawing: se_086171 rev h feature: sleeve internal diameter specification: 4 +/-0.05 mm measured dimension: 4.02 mm device used: mitutoyo digimatic caliper a20276546 id# cd78619.Device history review: part number: 395.922, lot number: 733p946, manufacturing site: haegendorf, release to warehouse date: 31.03.2022.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.

• Brand Name: DRILLSL 4
• 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: 16532213
• Report Number: 8030965-2023-03112
• Device Sequence Number: 14981692
• Product Code: LXH
• UDI-Device Identifier: 07611819739062
• UDI-Public: (01)07611819739062
• 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: Other Health Care Professional
• Type of Report: Initial,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 Catalogue Number: 395.922
• Device Lot Number: 733P946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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 L125/40 TI; SELDRILL-SCHANZSCR Ø4/2.5 L80/20 TI; SELDRILL-SCHANZSCR Ø4/2.5 L80/20 TI; SELDRILL-SCHANZSCR Ø4/3 L100/20 TI
• Patient Sex: Unknown