MAUDE Adverse Event Report: SYNTHES BRANDYWINE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS, LONG; GAUGE, DEPTH

Catalog Number 319.007

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was reportedly no patient involvement.Unknown when device broke.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Part 319.007, lot 4661091: release to warehouse date: january 23, 2013.Supplier- (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 that would contribute to this complaint condition.A material review report was issued for subcomponent 319.007.02, 3 out of 3 items inspected length was not to specifications; therefore all 48 items produced were reworked and released per specifications.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes (b)(4) reported that two balls on the shaft on the depth gauge were discovered broken after the cleaning process.This was outside of the operating room; there was no patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: this complaint is confirmed.The two miniature balls which are installed in the slider component during manufacture are missing from the slider and were not returned.Unable to determine a definitive root cause for this complaint condition.However, the complaint condition was most likely caused by application of excessive force or cumulative wear over the 12 year lifetime of this device.It is not likely that the design of the device contributed to this complaint.A visual inspection under 5x magnification, device history record (dhr) review, complaint history review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Per the product brochure, the returned depth gauge is an instrument used to measure screw length for 2.0mm and 2.4mm screws in the orthognathic modular fixation system.The relevant drawings were reviewed during this evaluation.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS, LONG
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5782085
• MDR Text Key: 49172891
• Report Number: 2530088-2016-10187
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.007
• Device Lot Number: 4661091
• Other Device ID Number: (01)10887587039008(10)4661091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1