MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM/1.0MM DOUBLE DRILL SLEEVE; GUIDE

Catalog Number	319.134
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Dhr review was completed.Part: 319.134; lot: 8981181; manufacturing site: (b)(4); release to warehouse date: 09.July 2014.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all functional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Customer quality investigation: the following investigations were performed: functional: device condition: visual inspection performed at customer quality under 10x magnification observed deformed surfaces in the 1 mm drill sleeve cannulation which is consistent with the reported complaint condition.No new issues were identified other than the slight discoloration at the welded joints which would not affect the intended functionality of the device.Functional inspection performed at customer quality observed stuck condition when the gage pin of given drawing specification was used into ø1 mm sleeve cannulation.The complaint condition of device not functioning was able to be replicated and the complaint was confirmed.Does the received condition agree with the complaint description- yes, the complaint condition is confirmed.Document and specification review: following drawings were reviewed and no design issues were identified.Top level drawing: component level drawing: ø1 mm drill guide: component level drawing: ø1.3 mm drill guide: dimensional analysis performed on ø1 mm sleeve cannulation of the device accepted gage pins of 0.88 mm (gp:29) that falls out of the specification of 1.02 +0.05/-0.00.The observed deformation is due to post manufacture damage.Dimensional analysis performed on ø1.3 mm sleeve cannulation of the device accepted gage pins of 1.34 mm (gp:29) that falls within of the specification of 1.32 +0.05/-0.00.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.No definitive root cause was able to be determined however, it is likely that the complaint condition is the result of unintended off-axis forces by the mating device.Conclusion: the complaint is confirmed.However, no product design or manufacturing issues were identified.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 during an unknown surgical procedure on (b)(6) 2018, the modular head of the double drill sleeve was not functioning properly.Surgeon used the control guide to complete the procedure successfully with no delay.Patient status reported as stable.This report is for one (1) double drill sleeve.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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: 1.3MM/1.0MM DOUBLE DRILL SLEEVE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8196608
• Report Number: 2939274-2018-55571
• Device Sequence Number: 18906139
• Product Code: FZX
• UDI-Device Identifier: 10886982190031
• UDI-Public: (01)10886982190031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 319.134
• Device Lot Number: 8981181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 65