MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC HOLDING SLEEVE-STANDARD FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.632.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: no patient involvement was reported.Date device became dull/stripped is not known.Device is an instrument and is not implanted/explanted.(b)(6).Part 03.632.001, lot 6778547: release to warehouse date: january 06, 2012.(b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was completed: per the technique guide, the matrix holding sleeve (b)(4) is one of ten (10) holding sleeves for the matrix spine system utilized during screw insertion.The matrix system is covered by three technique guides: matrix ¿ deformity, matrix-degenerative and matrix ¿ mis.Once the holding sleeve is engaged with the driver shaft, it can be threaded into the proximal end of the matrix screw by rotating the holding sleeve¿s green knob clockwise until it is fully engaged.The returned matrix holding sleeve (b)(4) was examined and the threaded tip was found to be broken and missing a segment.No dimensional analysis was able to be completed due to post-manufacturing damage.No definitive root cause was able to be determined; the failure mode is consistent with the application of an off-axis load while engaging a screw.The complaint condition was unable to be replicated due to post-manufacturing damage.Relevant drawings for the returned matrix holding sleeve (b)(4) were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A design change was implemented to address the failure mode of the holding sleeve threaded tips breaking.The tip geometry on the inner sleeve was changed to a more constant outer diameter in order to improve product performance; the returned instrument was manufactured after the implementation of these changes.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no material review reports, non-conformance reports or complaint-related issues were identified with the lot number which may have contributed to the 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.
Event or Problem Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the distal end of two (2) separate sport grip t25 stardrive screwdriver shafts are slightly stripped.It was also noted the screwdriver sleeve has a metal ring damage, suspected to be due to wear and tear.Issue was discovered while scrub nurse was setting up prior to surgery, no patient involvement.When the device was received by the manufacturer, it was noted that the distal threads were partially broken off the holding sleeve.It was also noted that the screwdriver tips have some small gouges in them.(b)(4).

• Brand Name: HOLDING SLEEVE-STANDARD FOR MATRIX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7168497
• Report Number: 2939274-2018-50088
• Device Sequence Number: 1476237
• Product Code: LXH
• UDI-Device Identifier: 10705034718668
• UDI-Public: (01)10705034718668(10)6778547
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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: 03.632.001
• Device Lot Number: 6778547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1