MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STANDARD INSERTION HANDLE; MISC ORTHO SURGICAL INSTR EXEMPT

Catalog Number 03.010.045

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, when the set was being cleaned and decontaminated after the tibial nailing procedure, the connector was difficult to remove from the insertion handle.The threads on both items were damaged in the process of separating the devices.There was no procedure nor patient involvement.This complaint involves two (2) devices.This report is for one (1) standard insertion handle.This report is 1 of 2 for (b)(4).

Event Description

The threads of the connector were damaged in the process of separating the devices.

Manufacturer Narrative

Part: 03.010.045; lot: 7669841; manufacturing site: (b)(4); release to warehouse date: november 28, 2011 the device history record (dhr) shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation selection investigation site: cq zuchwil selected flow(s): 2.Device interaction/functional and 3.Damaged: visual | examples: deformed/bent/cracked visual inspection: upon visual inspection of the complaint device it can be seen that the part received shows some dents, scratches and slight deformation form use, but none of them are use relevant.Based on this, and that the insertion handle has no thread for the connection to the article 03.010.047, and because of that no allegation against this part, the complaint is not confirmed.Functional test: during manufacturing investigation, a functional test was performed.The insertion handle passed the functional test.Document/specification review: drawings and revisions are in accordance to dhr of production lot 7669841.All relevant features are defined on the used drawing revisions of dhr of production lot 7669841.Dimensional inspection: the investigation has shown that the article does function as intended, therefore no dimensional inspection is needed.Summary: unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: STANDARD INSERTION HANDLE
• Type of Device: MISC ORTHO SURGICAL INSTR EXEMPT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8243080
• MDR Text Key: 132924426
• Report Number: 8030965-2019-59813
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819760837
• UDI-Public: (01)07611819760837
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

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: 03.010.045
• Device Lot Number: 7669841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/13/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 01/31/2019
• Patient Sequence Number: 1