MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK; CERCLAGE FIXATION

Catalog Number 08.501.001.20S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.Unknown when device broke.Other udi: (b)(4) lot unknown.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).(b)(4).Without a lot number, the device history record review and the investigation 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

Device report from synthes on an event in (b)(6) as follows: it was reported that one piece of zip fix was broken in the patient, post-cabg (coronary artery bypass surgery).Broken piece was retrieved.Surgeon opened the wound and pull out the implant to complete the procedure.Patient status is stable.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Other udi: (b)(4).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

Additional narrative: other udi: (b)(4) unknown.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

Additional narrative: date returned to manufacturer 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 history records review was conducted.The report indicates that: dhr review for part.Part# 08.501.001.20s / lot: 9592331 manufacturing site: (b)(4) supplier: (b)(4) manufacturing date: 16 october 2015 expiry date: 01 october 2020 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.Other udi: (b)(4) synthes manufacturing location was discovered upon receipt of subject device.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.Patient initials, age, and gender were received.Patient id reported as # (b)(6).Patient weight is unavailable.A product development investigation was performed.Only a part including the detached head of approximately 90 mm length of the complained zip fix implant was received for investigation.The remaining and around 200 mm measuring part was not received and is missing.The available portion of the implant shows various damage and deformation.Because of the damage the complaint relevant dimensions cannot be checked to specifications anymore.The deformations to the returned device indicate a handling error by the user during the intra-operative application.The severe tooth deformation as seen on the ¿cut end¿ section would have damaged the locking tooth within the locking head.The root cause of these deformations is unknown.However, some initial fixation was achieved with the device, which can be said since some tooth deformation as we would expect.This indicates that the locking feature was engaged to the locking tooth on the device body but not fully.Therefore, the device opened after placement.The dhr review shows that the production procedure was according to the specifications at the manufacturing time in 2015 and there were no issues that would contribute to this complaint condition.Due to insufficient information no root cause to failure can be identified.No design related root cause has been identified on the returned device.Based on our investigations and including the received information the complaint root cause is deemed indeterminable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on november 4, 2016.The patient appeared in the clinic a week before the removal surgery and said he had a lump in front of his sternum.He had no pain.Physical examination revealed the broken zip fix wire near the head, beneath the skin palpable.Removal surgery was performed on (b)(6) 2016.No abnormality of tissues surrounding the zip fix, normal granulation tissue and intact sternum was seen.The surgery, which took ten (10) minutes, was entirely specifically to retrieve the broken zip fix.

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5978421
• MDR Text Key: 55649984
• Report Number: 2520274-2016-14693
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• 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,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: 9592331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR