MAUDE Adverse Event Report: SYNTHES GMBH 1.5 THREADED DRILL GUIDE DEPTH GAUGE; GUIDE, SURGICAL, INSTRUMENT

Model Number	323.034
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on february 08, 2023, during intra-op depth gauge didn't slide smoothly and thet6 star-driver was stripped, the 2.0 locking towers wouldn't lock into plate.There was no surgical delay.Procedure was completed successfully.It was unknown if there was fragments generated.There was no patient consequences.This complaint involves four (4) devices.This report is for one (1) 1.5 threaded drill guide depth gauge this is report 3 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint #(b)(4).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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4, h4 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 323.034 lot: 9107007 manufacturing site: werk hagendorf supplier:na release to warehouse date: 07 oct 2014 expiration date: na 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 lcp drill sleeve 2 w/scal f/drill bits ø, p/n: 323.034, lot: 9107007, exhibits signs of normal use.No significant product problem was observed on the surface of the device.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test to assess the assembly allegation was not conducted since the mating device was not returned for evaluation.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 lcp drill sleeve 2 w/scal f/drill bits ø, p/n: 323.034, lot: 9107007 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.

• Brand Name: 1.5 THREADED DRILL GUIDE DEPTH GAUGE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16457315
• Report Number: 8030965-2023-02437
• Device Sequence Number: 2315878
• Product Code: FZX
• UDI-Device Identifier: 10886982190604
• UDI-Public: (01)10886982190604
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: 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 Model Number: 323.034
• Device Catalogue Number: 323.034
• Device Lot Number: 9107007
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2014
• 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: 1.5 THREADED DRILL GUIDE DEPTH GAUGE; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0; UNK - PLATES: TRAUMA
• Patient Sex: Unknown