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

Catalog Number 319.006

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: march 19, 2001.Manufacture site: synthes (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported the depth gauge for 2.0mm and 2.4mm screws was found missing the inner portion with the depth markings.Device was found broken in two (2) pieces.Issue was discovered in central sterilization, no patient or surgical involvement.This report is for one (1) depth gauge.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The returned instrument was evaluated at customer quality and the complaint was able to be confirmed, however, the device was not missing the reported component that has the depth markers (slider).The needle had broken off from the slider component.The condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.There is a protection sleeve (not returned) to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Replication of the complaint is not applicable as the complaint conditions were visually confirmed.This complaint is confirmed.The 319.006 depth gauge is part of at least 14 technique guides, including the 2.4 mm variable angle lcp distal radius system and is used to measure the depth of the holes for the 2.0mm/2.4mm screws to ensure the correct screw length is used during the procedure.The information is provided per the 2.4 mm variable angle lcp distal radius system technique guide dsus/trm/0515/0599.Relevant product drawings were reviewed: no drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The thickness of the needle (1.25 mm) is driven by the fact that the needle must fit into a drilled hole of 1.5 mm, and the length (80 mm) is determined so the slider can measure screws up to 40 mm.The material of the needle probe component (part # 319.006.03) is extra hard 316ss, which is an appropriate material for an instrument component of this type.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.There is a protection sleeve (not returned) to protect the needle during transport; and the outer body adds additional protection to the needle attachment point during storage.No new, unique, or different patient harms were identified as a result of this investigation.The design is determined to be adequate for its intended use when used 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
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6444000
• MDR Text Key: 71222317
• Report Number: 2530088-2017-10079
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943(10)4247608
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 4247608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2001
• 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