MAUDE Adverse Event Report: SYNTHES MONUMENT HAMMER GUIDE FOR SLIDE HAMMER; HAMMER, SURGICAL

Catalog Number 357.22

Device Problems Dull, Blunt (2407); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event date: unknown.Other¿partial udi# (b)(4) lot number unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial reporter: reporting facility phone number is (b)(6).The subject device is expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Mfg date: unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) reported the following event: it was reported that a trochanter fixation nail system (tfn) guide hammer was stripped during a total knee replacement.It is unknown if fragments were generated; however, no fragments reportedly remained in the patient.The patient's post-operative status is unknown.It is unknown if there was a surgical delay due to the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the following complaint device was received for evaluation: one hammer guide for slide hammer (part: 357.22 / lot: 6624487).The complaint condition for the hammer guide was likely caused by the instrument being dropped prior to the procedure.The hammer guide for slide hammer (357.22) is a common trauma instrument referenced in cannulated retrograde/antegrade femoral nail, titanium cannulated tibial nail, and titanium trochanteric fixation nail technique guides.In each instance, the hammer guide can be utilized along with a slide hammer and driving cap for nail insertion and removal.The returned instrument was examined and the complaint condition was able to be confirmed as the threaded distal end of the instrument was found to be deformed on one section.No definitive root cause was able to be determined; however, the failure mode is consistent with the instrument possibly being dropped resulting in the complaint condition.The relevant drawing was reviewed.The design history was found to not impact the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The complaint condition for the hammer guide was likely caused by the instrument being dropped prior to the procedure.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device history record review: manufacturing date: june 13, 2011 ¿ manufacturing location: (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.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.

Event Description

Correction: the performed procedure was a fractured hip repair not a total knee replacement as originally reported.

• Brand Name: HAMMER GUIDE FOR SLIDE HAMMER
• Type of Device: HAMMER, SURGICAL
• 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: 5370483
• MDR Text Key: 36099230
• Report Number: 2520274-2016-10255
• Device Sequence Number: 1
• Product Code: FZY
• 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
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.22
• Device Lot Number: 6624487
• Other Device ID Number: (01)10886982195913(10)6624487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2011
• 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