MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS; NAIL, FIXATION, BONE

Model Number	03.010.436
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Part returned.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested and is currently pending completion.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, during an unknown procedure, the suprapatellar sleeve seems to be defective, would not fit into the protection sleeve.Another set was grabbed on the shelf and the inner sleeve would fit just fine through the new sleeve.There was a surgical delay of five minutes.It is unknown if the procedure was successfully completed.No patient consequence.This complaint involves one (1) devices.This report is for one (1) 14.5mm protection slv straight for 12mm-13mm nails.This report is 1 of 1 for (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.H10 additional narrative: h11: g4.Pma/ 510(k) correction if additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.G4.
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.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
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.H3, h6: investigation summar.Please note investigation will be done on both image and actual device.Investigation flow: device interaction/functional photo review: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s) received through mar 04, 2021.The image(s) was reviewed, and the complaint condition(s) of device interaction was not confirmed as the images provided do not show any issues that would prevent the device from functioning as intended.Visual inspection: upon visual inspection no damage was noted on the instrument that would contribute to the complaint condition.Functional test : the functional test was failed to perform on the returned device as the mating device (wire guide/2 holes 14.5/3.2mm for suprapatellar, part number 03.010.434) was not returned.Document/specification review: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Investigation conclusion: there is no indication that a design or manufacturing issue contributed to the complaint as it was unconfirmed.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part number:03.010.436, synthes lot number: h146910, supplier lot number: n/a, release to warehouse date: jun 14, 2017, expiration date: n/a, supplier: (b)(4).Nc #nr0071282 was generated during production for part fails transparency check, measured above spec limit.Part was returned to vendor.Relevance to complaint condition cannot be determined until the product is returned for investigation.Device history review: review of the device history record showed that there are potential issues during the manufacture of the product that 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.

• Brand Name: 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11463766
• Report Number: 2939274-2021-01288
• Device Sequence Number: 11667335
• Product Code: JDS
• UDI-Device Identifier: 10886982068774
• UDI-Public: (01)10886982068774
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2021

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: 03.010.436
• Device Catalogue Number: 03.010.436
• Device Lot Number: H146910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 03/16/2021; 04/08/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/12/2021; 04/05/2021; 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS; WIRE GUIDE/2 HOLES 14.5/3.2MM FOR SUPRAPATELLAR