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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH 11MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY

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SYNTHES SELZACH 11MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 456.410S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Sedation (2368); No Code Available (3191)
Event Date 04/19/2016
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Additional narrative: patient id & dob not available for reporting. Additional product code: hwc. (b)(4). Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. (b)(6). The complaint indicated that the device was implanted in the patient, malfunction (locking mechanism "broke") and then had to be removed and a new device implanted which resulted in a 30 minute surgical delay. Device history records was conducted. The report indicates that the: dhr review is for sterilization procedure only: manufacturing site: (b)(4), supplier: (b)(4)(sterilization), 456. 410s ¿ 9345140. Manufacturing date: 29. Jan. 2015 (delivered from supplier to (b)(4)) expiry date: 01. Jan. 2025. This complaint is assessed as not related to sterilization. Thus, the documents for the corresponding non sterile were reviewed with the following result: no ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Dhr, as the non-sterile part was produced and delivered from the u. S. 456. 410 ¿ 7780834. A review of depuy synthes (b)(4) device history records for manufacturing revealed no issues for this complaint number no manufacturing related issue was identified and/or confirmed therefore review to prm and prm line is not applicable for part number: 456. 410, lot number: 7780834, manufacture date: 09/02/14, expiration date: n/a sold as non-sterile, dhr review date: 04/28/16. 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 on an event in (b)(6) as follows: it was reported that the locking mechanism broke. The event occured during surgery, there were no patient harm, no reoperation was necessary, no fragments were generated, and the procedure was successfully completed, the surgery was prolonged for 30 minutes, patient outcome is ok. This complaint involves 1 part. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. 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.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
Product investigation summary: one (1) 11mm diameter, 130 degree titanium cannulated trochanteric fixation nail (part 456. 410s / lot 7780834) was returned with a complaint stating that the locking mechanism broke intra-operatively. A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. The nail was returned with the locking mechanism dislodged and broken into two (2) pieces. The broken leg of the locking mechanism was twisted towards the left. The lower left corner of the broken leg was heavily damaged, indicating that it withstood a significant amount of impact. The nail itself was in very good condition. Replication of the complaint is not applicable as the device was returned broken. The complaint does not indicate the events that led to the breakage of the locking mechanism, so a definitive root cause cannot be determined. However, the pattern of the damage is indicative of excessive force against the leg of the helical blade. It is likely that the locking mechanism was partially engaged prior to inserting the helical blade. The force exerted while hammering the helical blade into the femoral head most likely weakened the thin material to the point of breakage. The titanium cannulated tfn nail is an implant routinely used in the ti-tfn system. The tabulated product drawings were reviewed during the investigation. The device was manufactured from titanium alloy (titanium aluminum niobium). The design is adequate for its intended use when used and maintained as recommended and did not contribute to the complaint condition. No non-conformance reports were generated during production. 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. No new, unique, or different patient harms were identified as a result of this evaluation. The design is adequate for its intended use when used and maintained as recommended. Device broke intra-operatively and, therefore, is not considered to have been implanted or explanted. (b)(4): the reported device broke intra-operatively. As a result, the inserted device was removed and replaced with an alternate device during the same procedure. As such, the issue resulted in a delay and additional medical intervention. 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.
 
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Brand Name11MM/130 DEG TI CANN TROCH FIXATION NAIL 300MM/RIGHT-STER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ CH2545
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5641905
MDR Text Key44775996
Report Number3000270450-2016-10114
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK011857
Number of Events Reported1
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 04/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.410S
Device Lot Number9345140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/09/2016 Patient Sequence Number: 1
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