MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM THREADED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	312.648
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a sales representative.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
It was reported that on an unknown date, during inspection of back up it was noted that the two (2) threaded drill sleeve are pressed, so they are flat.There was no patient involvement.This report is for one (1) 2.8mm threaded drill guide.This is report 2 of 2 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.H3, h6: a product investigation was conducted: investigation flow: visual/ damage.Visual inspection: 2.8mm threaded drill guide (p/n: 312.648 & lot #: 4794894) was received at us cq.Upon visual inspection, it is observed that the threads on the distal end of the device were stripped.Also the etch on the device was not clear.No other issues were identified on the device.Device failure/ defect found? yes.Dimensional inspection: dimensional inspection was not performed due to post manufacturing defect.Document/ specification review: no design issues or discrepancies were noted during the investigation.Complaint confirmed? yes.Investigation conclusion: a visual inspection and document/specification review were performed for 2.8mm threaded drill guide (p/n: 312.648 & lot #: 4794894) as part of this investigation.The distal end threads of the device were observed to be stripped and the etching on the device was illegible.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 312.648.Synthes lot number: 4794894.Supplier lot number: n/a.Release to warehouse date: jul 08, 2004.Expiration date: n/a.Manufactured by synthes brandywine.No ncrs were generated during production.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: updated data: d4.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: 2.8MM THREADED DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10237308
• Report Number: 2939274-2020-03109
• Device Sequence Number: 3093366
• Product Code: FZX
• UDI-Device Identifier: 10886982187840
• UDI-Public: (01)10886982187840
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2020

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: 312.648
• Device Catalogue Number: 312.648
• Device Lot Number: 4794894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 08/04/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/31/2020; 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1