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

Catalog Number 319.006

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported unknown when device malfunctioned/missing component.Device is unknown and is unknown if implanted/explanted.(b)(6).No dhr review is possible as part and lot number combination could not be found.The dhr review can be reevaluated if new information is received.Without a lot number the device history record review and the investigation is unconfirmed, therefore, it could not be completed; no conclusion could be drawn, as no product was received if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a ball bearing on the side of depth gauge which protects sheath from sliding off, this has fallen out due to possibly no spring.This is a vet case, no patient involved.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device history record review: part number: 319.006 / lot number: 9897678.Manufacturing date: october 7, 2015 ¿ manufacturing location: (b)(4).No non-conformance reports were generated during production of this assembly or the relevant components.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.Device 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.

Manufacturer Narrative

Product investigation summary: the following was received: depth gauge (part 319.006 | lot 9897678).The returned depth gauge is in an excellent, unused condition.The device appears to be missing the spring that resides behind the ball on the side of the slider.The ball is present, but it is able to easily slide back and forth.Since the ball is still captive in the slider, it is likely that the device was incorrectly manufactured without the spring.The remainder of the device is undamaged, and the device is calibrated correctly per the device design.Further investigation will be performed.The associated drawing for the device(s) was reviewed with no drawing issues or discrepancies noted.The design is adequate for its intended use and did not contribute to this complaint condition.The received device is calibrated correctly per the design drawing.The device appears to have been manufactured without the spring.Therefore, this is a manufacturing process error.Device is an instrument and is not implanted or explanted.Device 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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: the following was received: depth gauge (part # 319.006 | lot # 9897678), the returned depth gauge is in an excellent, unused condition.The device appears to be missing the spring that resides behind the ball on the side of the slider.The ball is present, but it is able to easily slide back and forth.Since the ball is still captive in the slider, it is likely that the device was incorrectly manufactured without the spring.The remainder of the device is undamaged, and the device is calibrated correctly per the device design.This complaint is confirmed.This investigation summary is approved.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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5299969
• MDR Text Key: 33587849
• Report Number: 2520274-2015-17926
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• 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: 9897678
• Other Device ID Number: (01)07611819707238(10)9897678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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