MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM VA LOCKING DOUBLE DRILL GUIDE/FREEHAND F/1.5MM VAL PL; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.130.221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: initial reporter is a j&j employee.Complainant part is not expected to be returned for manufacturer review/investigation.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2022, that the tip of the drill guide was split.The procedure was successful and not delayed.This report is for one 1.1mm va locking double drill guide/freehand f/1.5mm val pl.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: a manufacturing record evaluation cannot be performed due to lot number being unknown.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image(s).Visual analysis of the photo revealed that due to poor quality photo it is not possible to confirm evidence of the reported complaint device va drill guide coax+freehand useab f/dri.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for va drill guide coax+freehand useab f/dri.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.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.Part: 03.130.225 lot: 2l99995 manufacturing site: bettlach release to warehouse date: 29.April 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Note: dhr information was retrieved from (b)(4) as it is the same lot number.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 va drill guide coax+freehand useab f/dri was observed with the tip of the drill bit broken.The broken fragment was returned in the evidence provided.No other issues were identified with the returned device.A dimensional inspection for the va drill guide coax+freehand useab f/dri was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 va drill guide coax+freehand useab f/dri 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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -va drill guide, coaxial + freehand f/drill bits ø1.1mm se_471039 rev.E / rev.D dimensional inspection: n/a.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: 1.1MM VA LOCKING DOUBLE DRILL GUIDE/FREEHAND F/1.5MM VAL PL
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BETTLACH; muracherstrasse 3; bettlach CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14495955
• Report Number: 8030965-2022-03471
• Device Sequence Number: 5799589
• Product Code: FZX
• UDI-Device Identifier: 07611819690660
• UDI-Public: (01)07611819690660
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 05/25/2022

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: 03.130.221
• Device Lot Number: 2L99995
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 10/04/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/11/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 25 YR
• Patient Sex: Male